Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703584
• Other study ID #: 03012016
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2016
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Buseralin

Other:
• Placebo

Drug:
• pregnyl

Locations

Country	Name	City	State
Canada	TRIO Fertility	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blastocyst rate		8 days after the randomization