Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

Brief Summary

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All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

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Detailed Description

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A prospective, randomized, double blinded clinical trial. Patients will undergo standard clinical and hormonal investigation as usual for IVF. Patients that will be given the standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1. hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36 hours prior to the oocyte aspiration. All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support.

In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta error of 80% the sample size needed is 276 total patients in both groups or 138 patients in each group.

Conditions

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Infertility

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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Double trigger

Triggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU)

Group Type EXPERIMENTAL

Buseralin

Intervention Type DRUG

pregnyl

Intervention Type DRUG

control

Triggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

pregnyl

Intervention Type DRUG

Interventions

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Buseralin

Intervention Type DRUG

Placebo

Intervention Type OTHER

pregnyl

Intervention Type DRUG

Other Intervention Names

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Suprefact normal saline hCG

Eligibility Criteria

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Inclusion Criteria

* Women during one of their first 3 IVF cycle attempts
* Women between the ages of 18-42.
* BMI (body mass index) of 18-35.
* AMH (Anti mullerian hormone) \> 1 ng/ml
* FSH˂ 20 IU/L.
* Informed consent.

Exclusion Criteria

* Women with low ovarian response
* Previous enrollment in this study.
* AFC\>20
* E2 above 15,000 pmol/l at the trigger day.
* hypersensitive to Suprefact/Pregny/gonal F/Purigon/Menopur/progesterone, and/or their ingredients/components of the formulation
* primary ovarian failure
* pregnancy and breast-feeding
* active blood clots
* undiagnosed uterine or genital bleeding
* endometriosis
* uncontrolled hypertension;
* uncontrolled diabetes
* abnormal liver and kidney functions
* abnormal ECG, e.g. QT prolongation and torsades de pointes
* cancers/tumors, e.g. pituitary adenomas, ovarian cysts, etc.
* HIV, HBV and HCV infections
* low bone mineral density (BMD) and an increased risk of bone fracture, such as chronic alcohol and/or tobacco use, presumed or strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids
* suicidal tendency, history or disposition to seizures, state of confusion, clinically relevant psychiatric disorders, and brain lesions
* Use of an investigational drug or participation in an investigational study within 30 days prior to this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes