Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
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|ClinicalTrials.gov Identifier: NCT01815138|
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : September 25, 2017
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Hyperstimulation Syndrome||Drug: hCG||Phase 4|
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.
Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.
The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Double-blind Randomized Trial Comparing Pregnancy Rates After Low Dose Human Chorionic Gonadotropin (hCG) at the Time of Gonadotropin Releasing Hormone (GnRH) Agonist Trigger or 35 Hours Later for the Prevention of OHSS|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||October 2016|
Experimental: hCG given at time of GnRHa trigger
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.
Placebo administered 35 hours after GnRH agonist trigger
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Other Name: Pregnyl, Profasi
Active Comparator: hCG given 35 hours after GnRHa trigger
Placebo administered at the time of GnRH agonist trigger
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Other Name: Pregnyl, Profasi
- Ongoing Pregnancy [ Time Frame: Through time of study completion, on average 1-2years ]Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
- Ovarian Hyperstimulation Syndrome [ Time Frame: Within 4 weeks of oocyte retrieval ]Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.
- Markers of Corpus Luteum Function [ Time Frame: Within 60 days after trigger of oocyte maturation ]A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.
- Proportion of Patients With Abdominal Distension [ Time Frame: Within 2 weeks after trigger of oocyte maturation ]Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815138
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Lawrence Engmann, MD||UConn Health|