Study of Dual Trigger Ovulation in Oocyte Donors

NCT01443546 | Terminated Phase 4 Results DMC

• 1 other identifier: 1011011394
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.

Conditions

Infertility

Keywords

oocyte donor; oocyte recipient; ovulation trigger

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Having Adverse Events

  Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded

  1 month

• Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities

  Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.

  7 days post retrieval

• Ovarian Volume

  Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.

  7 days post retrieval

Secondary Outcomes (2)

• Number of Mature Oocytes Retrieved

  1 day post ovulation

• Pregnancies Per Transfer

  4 weeks post retrieval

Study Arms (3)

hCG

ACTIVE COMPARATOR

standard dose of hCG for ovulation trigger

Drug: HCG

Lupron Trigger

ACTIVE COMPARATOR

Leuprolide acetate 2 mg ovulation trigger

Drug: Lupron Trigger

Dual Trigger

EXPERIMENTAL

Lupron and hCG combined ovulation trigger

Drug: Dual Trigger

Interventions

HCG DRUG

hCG Trigger

hCG

Lupron Trigger DRUG

leuprolide acetate 2 mg SQ

Lupron Trigger

Dual Trigger DRUG

a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).

Dual Trigger

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Donors
• Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation.
• Recipients
• Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.

You may not qualify if:

• Donors
• Less than 2 ovaries or any other significant ovarian abnormality
• Does not meet current FDA or program requirements for donation.
• A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
• A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
• Known gene defects, genetic abnormalities or abnormal karyotype
• Contraindication or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
• Inability to give informed consent
• Donors who, because of their place of residence or personal situation, would not be able to commit to all required time points including the one extra visit required by study participation.
• The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

New York, New York, 10021, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Ina Cholst, MD
• Organization: Weill Cornell Medical College

icholst@med.cornell.edu

646-962-3025

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: September 29, 2011
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 26, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)