Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decapeptyl
hCG luteal support
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Fertilization in vitro, Luteal Phase, ovarian hyperstimulation syndrome
Eligibility Criteria
Inclusion Criteria:
- IVF treatment
- GnRH antagonist protocol
- GnRH agonist triggering of ovulation
- High risk for OHSS as expressed by either E2 serum level >2500 pg/ml
Exclusion Criteria:
- background maternal morbidity
- Any protocol other than GnRH antagonist protocol
- hCG triggering of ovulation
- E2 serum level >4500 pg/ml
- Aspiration of >25 ova
- Embryo transfer prior to day 5
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Decapeptyl support
hCG luteal support
Arm Description
S.C single luteal Decapeptyl 0.1 mg on days 3, 6,9 post ovulation triggering
S.C single luteal S.C recombinant hCG 50 micrograms on days 3 ovulation triggering
Outcomes
Primary Outcome Measures
Progesterone serum level
Secondary Outcome Measures
positive pregnancy test
implantation rate
clinical pregnancy rate
clinical pregnancy is considered as a presence of a viable embryo (heart activity present)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02827656
Brief Title
Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS
Official Title
Luteal Phase Support With Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRh) Agonist in IVF Patients Who Are Risk for Developing OHSS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare two luteal support protocols in In vitro fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation triggering is as good as low dose hCG on day 3 post triggering..
Detailed Description
This is randomized clinical trial studying two luteal support protocols of In vitro fertilization patients (IVF) treated by a GnRH antagonist (GnRH ant) protocol and are at risk of developing ovarian hyperstimulation syndrome (OHSS). The randomization procedure will be performed by a third party in the hospital by using a randomization table: patients fulfilling the inclusion and exclusion criteria and giving their informed consent will be randomized into one of two arms. This study does not include any intervention affecting the ovarian stimulation and is solely intended to test the post ova pickup period.
One arm will be treated by luteal Decapeptyl on days 3, 6,9 post ovulation triggering. Second arm will be treated by low dose hCG on day 3 post triggering. All patients to be recruited are treated for acceptable IVF indications in Meir medical center (MMC) and their registry is computerized in the general system of MMC. For the purpose of the study we will use the only the data of patients recruited to the study and were giving their informed consent. Each patient recruited will have a unique study identity (ID) . The patients' information will be pooled from the computerized file into an Excel spread sheet: in this Excel file the names will be erased and only the unique study ID will appear. The information regarding the coding key will be kept as a hard copy in a locked room inside the IVF unit in a special study folder. The study was approved by MMC institutional Helsinki board.
The data retrieved for each patients is not unique for the study but includes the basic variables monitored in every IVF cycle : Estradiol serum levels (E2), Progesterone serum levels (P), number of follicles as counted by trans-vaginal ultrasound, endometrial thickness as measured by trans-vaginal ultrasound, Follicle stimulating hormone (FSH) dosing, number of stimulation days, number of eggs retrieved, fertilization rate, blastulation rate, number of embryos transferred, embryo quality, positive pregnancy test, implantation rate, presence of a clinical pregnancy, presence of OHSS. Since these are mandatory variables in the treatment we do not expect any missing data. In addition to these mandatory data the study patients will be performing two additional blood tests on day 3 post ovum pickup and on the transfer day itself (day 5 post ovum pickup) including Estradiol serum levels (E2) and Progesterone serum levels (P).
Outcome measures: Day of transfer Progesterone serum levels, OHSS rate, implantation rate, clinical pregnancy rate.
Sample size calculation based on Kol S et al 2015, regarding the day of transfer Progesterone level (pooled standard deviation: 40nmol/L), alpha of 5%, 80% power, then a non-inferiority study will require 22 patients in each group and a total of 44 patients. Once including an expected 10% chance of freeze all in this population we will include 50 patients.
Statistical analysis: Analysis of data was performed using the SPSS 23.0 computer package (SPSS Inc., Chicago, IL). Normally distributed data were analyzed by student t test . χ2 or Fisher's exact test will be used for comparisons of rates and proportions. All P values were tested as two-sided and considered significant at less than 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Fertilization in vitro, Luteal Phase, ovarian hyperstimulation syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decapeptyl support
Arm Type
Experimental
Arm Description
S.C single luteal Decapeptyl 0.1 mg on days 3, 6,9 post ovulation triggering
Arm Title
hCG luteal support
Arm Type
Active Comparator
Arm Description
S.C single luteal S.C recombinant hCG 50 micrograms on days 3 ovulation triggering
Intervention Type
Drug
Intervention Name(s)
Decapeptyl
Intervention Description
luteal support as described and vaginal progesterone 200 mg 3 times a day
Intervention Type
Drug
Intervention Name(s)
hCG luteal support
Intervention Description
luteal support as described and vaginal progesterone 200 mg 3 times a day
Primary Outcome Measure Information:
Title
Progesterone serum level
Time Frame
day 5 post ovum pickup
Secondary Outcome Measure Information:
Title
positive pregnancy test
Time Frame
9-12 days post embryo transfer
Title
implantation rate
Time Frame
30-33 days post embryo transfer
Title
clinical pregnancy rate
Description
clinical pregnancy is considered as a presence of a viable embryo (heart activity present)
Time Frame
30-33 days post embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
IVF treatment
GnRH antagonist protocol
GnRH agonist triggering of ovulation
High risk for OHSS as expressed by either E2 serum level >2500 pg/ml
Exclusion Criteria:
background maternal morbidity
Any protocol other than GnRH antagonist protocol
hCG triggering of ovulation
E2 serum level >4500 pg/ml
Aspiration of >25 ova
Embryo transfer prior to day 5
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Klement, MD
Email
anat.klement@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Helsinki Committee MMC
Phone
97297471588
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Wiser, MD
Organizational Affiliation
MMC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21828116
Citation
Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
Results Reference
background
PubMed Identifier
25358904
Citation
Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;(10):CD008046. doi: 10.1002/14651858.CD008046.pub4.
Results Reference
background
PubMed Identifier
10785212
Citation
Whelan JG 3rd, Vlahos NF. The ovarian hyperstimulation syndrome. Fertil Steril. 2000 May;73(5):883-96. doi: 10.1016/s0015-0282(00)00491-x.
Results Reference
background
PubMed Identifier
15760966
Citation
Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grondahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005 May;20(5):1213-20. doi: 10.1093/humrep/deh765. Epub 2005 Mar 10.
Results Reference
background
PubMed Identifier
21371705
Citation
Griesinger G, Schultz L, Bauer T, Broessner A, Frambach T, Kissler S. Ovarian hyperstimulation syndrome prevention by gonadotropin-releasing hormone agonist triggering of final oocyte maturation in a gonadotropin-releasing hormone antagonist protocol in combination with a "freeze-all" strategy: a prospective multicentric study. Fertil Steril. 2011 May;95(6):2029-33, 2033.e1. doi: 10.1016/j.fertnstert.2011.01.163. Epub 2011 Mar 2.
Results Reference
background
PubMed Identifier
26507279
Citation
Kol S, Breyzman T, Segal L, Humaidan P. 'Luteal coasting' after GnRH agonist trigger - individualized, HCG-based, progesterone-free luteal support in 'high responders': a case series. Reprod Biomed Online. 2015 Dec;31(6):747-51. doi: 10.1016/j.rbmo.2015.09.001. Epub 2015 Sep 9.
Results Reference
background
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Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS
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