Efficacy of Pergoveris in Aged IVF Patients
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Pergoveris (FSH and LH)
Follitropin alpha (FSH)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, LH supplementation, ovarian stimulation, poor responder
Eligibility Criteria
Inclusion Criteria:
- age ≥ 35 years
- body mass index <28 kg/m2
- had ≤ 3 previous IVF attempts
- receiving a GnRH-antagonist protocol
- agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- have given written informed consent with the understanding that the subject may withdraw consent at any time
Exclusion Criteria:
- participating in another interventional clinical trial
- PCOS or WHO group 1
- have uterine abnormalities
- have endocrine disorders such as hyperprolactinemia, thyroid disorders
Sites / Locations
- An Sinh Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pergoveris (FSH and LH)
Follitropin alpha (FSH)
Arm Description
150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection
150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection
Outcomes
Primary Outcome Measures
Clinical pregnancy
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Live birth
Live birth is defined if a live newborn delivered.
Secondary Outcome Measures
Total FSH international units (IU) used for stimulation
Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.
Full Information
NCT ID
NCT02244866
First Posted
September 16, 2014
Last Updated
December 23, 2014
Sponsor
Vietnam National University
1. Study Identification
Unique Protocol Identification Number
NCT02244866
Brief Title
Efficacy of Pergoveris in Aged IVF Patients
Official Title
A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.
Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.
Detailed Description
A randomized controlled single center study.
Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.
Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.
Ovarian stimulation was performed by using GnRH antagonist protocol.
Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:
AFC ≤ 6: 300 IU/day
AFC 7-15: 225 IU/day
AFC ≥ 16: 150 IU/day
GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.
Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.
The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.
Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.
OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.
Luteal phase support: daily vaginal progesterone
Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, LH supplementation, ovarian stimulation, poor responder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pergoveris (FSH and LH)
Arm Type
Active Comparator
Arm Description
150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection
Arm Title
Follitropin alpha (FSH)
Arm Type
Active Comparator
Arm Description
150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Pergoveris (FSH and LH)
Other Intervention Name(s)
Pergoveris
Intervention Description
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Intervention Type
Drug
Intervention Name(s)
Follitropin alpha (FSH)
Other Intervention Name(s)
Gonal-F
Intervention Description
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Time Frame
7 weeks after embryo transfer
Title
Live birth
Description
Live birth is defined if a live newborn delivered.
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Total FSH international units (IU) used for stimulation
Description
Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.
Time Frame
Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 35 years
body mass index <28 kg/m2
had ≤ 3 previous IVF attempts
receiving a GnRH-antagonist protocol
agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
have given written informed consent with the understanding that the subject may withdraw consent at any time
Exclusion Criteria:
participating in another interventional clinical trial
PCOS or WHO group 1
have uterine abnormalities
have endocrine disorders such as hyperprolactinemia, thyroid disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuong M Ho, MD
Organizational Affiliation
CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
An Sinh Hospital
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
25740882
Citation
Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged >/=35 years: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1188-95. doi: 10.1093/humrep/dev038. Epub 2015 Mar 3.
Results Reference
derived
Learn more about this trial
Efficacy of Pergoveris in Aged IVF Patients
We'll reach out to this number within 24 hrs