Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation- A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Placebo; Drug: Buseralin; Drug: pregnyl

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2K4
      • Trio Fertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double trigger; Triggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU)	Drug: Buseralin; Other Names: Suprefact; Drug: pregnyl; Other Names: hCG
Placebo Comparator: control; Triggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo	Other: Placebo; Other Names: normal saline; Drug: pregnyl; Other Names: hCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mature oocytes	We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)	2 days after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Blastocyst rate	8 days after the randomization

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Robert F Casper, MD, Scientific Director TRIO IVF

Publications and helpful links

General Publications

• Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Double trigger
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: 03012016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No