Back to resultsTo Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001) (Ensure)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
corifollitropin alfa (Org 36286)
recFSH (follitropin beta)
gonadatropin releasing hormone (GnRH) antagonist (ganirelix)
human chorion gonadatropin (hCG)
progesterone
placebo-recFSH (follitropin alfa)
placebo-corifollitropin alfa
open-label recFSH
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization, Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national, Double-blind, Active-controlled, Equivalence
Eligibility Criteria
Inclusion Criteria:
- Females of couples with an indication for COS and IVF or ICSI;
- >=18 and <= 36 years of age at the time of signing informed consent;
- Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
- Willing and able to sign informed consent.
Exclusion Criteria:
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyper-response or ovarian hyperstimulation syndrome
(OHSS);
- History of/or current polycystic ovary syndrome (PCOS);
- More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
- Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
- Presence of unilateral or bilateral hydrosalphinx (visible on USS);
- Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;
- More than three unsuccessful IVF cycles since the last established ongoing
pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
- History of recurrent miscarriage (3 or more, even when unexplained);
- FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
- Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
gastro-intestinal, hepatic, renal or pulmonary disease;
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- Smoking more than 5 cigarettes per day;
- History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- Previous use of Org 36286;
- Use of hormonal preparations within 1 month prior to randomization;
- Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
- Administration of investigational drugs within three months prior to signing informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
corifollitropin alfa 100 µg
recFSH 150 IU
Arm Description
Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
Outcomes
Primary Outcome Measures
Number of Cumulus-oocyte-complexes Retrieved, Per Attempt
The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.
Secondary Outcome Measures
Total Dose of recFSH Administered
Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).
Total Dose of recFSH Administered From Day 8 Onwards
Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).
Number of Days Treated With recFSH
Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).
Total Duration of Stimulation (Days)
Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).
Fertilization Rate
Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. "Other" grade embryos were those that did not qualify as Grade 1, 2, or 3.
Implantation Rate for Participants With ET
The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.
Number of Participants With Miscarriages
A miscarriage, also known as a "spontaneous abortion," was defined as the loss of a fetus without induction or instrumentation.
Number of Participants With Pregnancies
A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00702845
Brief Title
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Acronym
Ensure
Official Title
A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 28, 2006 (Actual)
Primary Completion Date
July 7, 2007 (Actual)
Study Completion Date
November 15, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.
Detailed Description
This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization, Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national, Double-blind, Active-controlled, Equivalence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
corifollitropin alfa 100 µg
Arm Type
Experimental
Arm Description
Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
Arm Title
recFSH 150 IU
Arm Type
Active Comparator
Arm Description
Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
Intervention Type
Drug
Intervention Name(s)
corifollitropin alfa (Org 36286)
Other Intervention Name(s)
Org 36286
Intervention Description
100 µg corifollitropin alfa subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
recFSH (follitropin beta)
Other Intervention Name(s)
recFSH (Puregon/Follistim AQ Cartridge)
Intervention Description
150 IU recFSH SC injection
Intervention Type
Drug
Intervention Name(s)
gonadatropin releasing hormone (GnRH) antagonist (ganirelix)
Intervention Description
GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day
Intervention Type
Drug
Intervention Name(s)
human chorion gonadatropin (hCG)
Intervention Description
hCG 5,000 IU or 10,000 IU administered SC
Intervention Type
Biological
Intervention Name(s)
progesterone
Intervention Description
Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Intervention Type
Drug
Intervention Name(s)
placebo-recFSH (follitropin alfa)
Intervention Description
Placebo-recFSH administered at the equivalent volume of 150 IU/day.
Intervention Type
Drug
Intervention Name(s)
placebo-corifollitropin alfa
Intervention Description
Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.
Intervention Type
Biological
Intervention Name(s)
open-label recFSH
Intervention Description
Open-label recFSH administered up to a maximum dose of 200 IU/day.
Primary Outcome Measure Information:
Title
Number of Cumulus-oocyte-complexes Retrieved, Per Attempt
Description
The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.
Time Frame
One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)
Secondary Outcome Measure Information:
Title
Total Dose of recFSH Administered
Description
Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).
Time Frame
One COS cycle (up to a maximum total duration of 19 stimulation days)
Title
Total Dose of recFSH Administered From Day 8 Onwards
Description
Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).
Time Frame
Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)
Title
Number of Days Treated With recFSH
Description
Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).
Time Frame
One COS cycle (up to a maximum total duration of 19 stimulation days)
Title
Total Duration of Stimulation (Days)
Description
Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.
Time Frame
One COS cycle (up to a maximum total duration of 19 stimulation days)
Title
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
Description
Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Time Frame
Predose up to 2 weeks after ET (up to maximum of 6 weeks)
Title
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
Description
Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Time Frame
Predose up to 2 weeks after ET (up to maximum of 6 weeks)
Title
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
Description
Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Time Frame
Predose up to 2 weeks after ET (up to maximum of 6 weeks)
Title
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
Description
Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Time Frame
Predose up to 2 weeks after ET (up to maximum of 6 weeks)
Title
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
Description
Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.
Time Frame
Predose up to 2 weeks after ET (up to maximum of 6 weeks)
Title
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
Description
For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.
Time Frame
Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)
Title
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
Description
The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).
Time Frame
Up to 36 hours after administration of hCG
Title
Fertilization Rate
Description
Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.
Time Frame
Up to 10 weeks after ET
Title
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
Description
Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. "Other" grade embryos were those that did not qualify as Grade 1, 2, or 3.
Time Frame
Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)
Title
Implantation Rate for Participants With ET
Description
The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.
Time Frame
Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)
Title
Number of Participants With Miscarriages
Description
A miscarriage, also known as a "spontaneous abortion," was defined as the loss of a fetus without induction or instrumentation.
Time Frame
Up to 10 weeks after ET (up to a maximum of 14 weeks)
Title
Number of Participants With Pregnancies
Description
A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.
Time Frame
Up to 10 weeks after ET (up to a maximum of 14 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females of couples with an indication for COS and IVF or ICSI;
>=18 and <= 36 years of age at the time of signing informed consent;
Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;
Normal menstrual cycle length: 24-35 days;
Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
Willing and able to sign informed consent.
Exclusion Criteria:
History of/or any current (treated) endocrine abnormality;
History of ovarian hyper-response or ovarian hyperstimulation syndrome
(OHSS);
History of/or current polycystic ovary syndrome (PCOS);
More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
Presence of unilateral or bilateral hydrosalphinx (visible on USS);
Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;
More than three unsuccessful IVF cycles since the last established ongoing
pregnancy (if applicable);
History of non- or low ovarian response to FSH/hMG treatment;
History of recurrent miscarriage (3 or more, even when unexplained);
FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
gastro-intestinal, hepatic, renal or pulmonary disease;
Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
Smoking more than 5 cigarettes per day;
History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
Previous use of Org 36286;
Use of hormonal preparations within 1 month prior to randomization;
Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
Administration of investigational drugs within three months prior to signing informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
20483664
Citation
Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28. Erratum In: Reprod Biomed Online. 2014 Sep;29(3):395.
Results Reference
result
PubMed Identifier
26991902
Citation
Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
Results Reference
derived
PubMed Identifier
26950065
Citation
Griesinger G, Verweij PJ, Gates D, Devroey P, Gordon K, Stegmann BJ, Tarlatzis BC. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol. PLoS One. 2016 Mar 7;11(3):e0149615. doi: 10.1371/journal.pone.0149615. eCollection 2016.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=P05690&kw=P05690&tab=access
Learn more about this trial
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
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