Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: pregnyl; Drug: Buseralin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02703584

03012016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 276 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

276 participants in 2 patient groups, including a placebo group

Double trigger

Experimental group

Description:

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

Treatment:

Drug: Buseralin

Drug: pregnyl

control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Drug: pregnyl