Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-31

Brief Summary

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This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels \< 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

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Detailed Description

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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.

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

hCG

Intervention Type DRUG

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

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.

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Interventions

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hCG

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Intervention Type DRUG

hCG

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Intervention Type DRUG

Other Intervention Names

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Pregnyl, Profasi Pregnyl, Profasi

Eligibility Criteria

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Inclusion Criteria

* Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have \> 14 follicles of over 11 mm in diameter and with peak serum E2 levels \< 4,000 pg/mL on the day of trigger of oocyte maturation.