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Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

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ClinicalTrials.gov Identifier: NCT02703584
Recruitment Status : Unknown
Verified June 2016 by Mount Sinai Hospital, Canada.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Buseralin Other: Placebo Drug: pregnyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation- A Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double trigger
Triggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU)
Drug: Buseralin
Other Name: Suprefact

Drug: pregnyl
Other Name: hCG

Placebo Comparator: control
Triggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo
Other: Placebo
Other Name: normal saline

Drug: pregnyl
Other Name: hCG




Primary Outcome Measures :
  1. Number of mature oocytes [ Time Frame: 2 days after randomization ]
    We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)


Secondary Outcome Measures :
  1. Blastocyst rate [ Time Frame: 8 days after the randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703584


Contacts
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Contact: Jigal Haas, MD 6478633495 jigalh@hotmail.com

Locations
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Canada, Ontario
TRIO Fertility Recruiting
Toronto, Ontario, Canada, M5G 2K4
Contact: Jigal Haas    6478633495    jigalh@hotmail.com   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Robert F Casper, MD Scientific Director TRIO IVF

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02703584    
Other Study ID Numbers: 03012016
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mount Sinai Hospital, Canada:
Double trigger
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Buserelin
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents