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Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Buseralin

Placebo

pregnyl

About this trial

This is an interventional treatment trial for Infertility focused on measuring Double trigger

Eligibility Criteria

18 Years - 41 Years (Adult)FemaleAccepts 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.

Sites / Locations

TRIO Fertility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Double trigger

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of mature oocytes

We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)

Secondary Outcome Measures

Blastocyst rate

Full Information

NCT ID

NCT02703584

First Posted

March 3, 2016

Last Updated

April 26, 2022

Sponsor

Mount Sinai Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT02703584

Brief Title

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Double trigger

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double trigger

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Buseralin

Other Intervention Name(s)

Suprefact

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

normal saline

Intervention Type

Drug

Intervention Name(s)

pregnyl

Other Intervention Name(s)

hCG

Primary Outcome Measure Information:

Title

Number of mature oocytes

Description

We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)

Time Frame

2 days after randomization

Secondary Outcome Measure Information:

Title

Blastocyst rate

Time Frame

8 days after the randomization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

41 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert F Casper, MD

Organizational Affiliation

Scientific Director TRIO IVF

Official's Role

Principal Investigator

Facility Information:

Facility Name

TRIO Fertility

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2K4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32563188

Citation

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.

Results Reference

derived

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Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

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