Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

• Status: Completed
• Trial end date: 2017-03-08
• Target enrollment: 0
• Participant gender: Female

Summary

Disprove the null hypothesis as follows:

Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™.

Objectives:

Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors.

Efficacy defined as:

1. #Days of ovarian stimulation to GnRH agonist trigger.

2. Peak serum estradiol level on day of GnRH agonist trigger.

3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.

4. Number of mature oocytes recovered and cryopreserved.

Study type: Randomized prospective clinical trial.

Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.

Study design:

Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.

Random number generator with patients assigned basd on odd or even numbers.

Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study.

Primary measure of outcome: number of mature oocytes recovered and cryopreserved.

Secondary measures of outcome:

1. #Days of ovarian stimulation to GnRH agonist trigger.

2. Peak serum estradiol level on day of GnRH agonist trigger.

3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michigan Reproductive Medicine
• Treatments: Deslorelin; Follicle Stimulating Hormone; Ganirelix; Leuprolide; Menotropins

Criteria

Inclusion Criteria:

• Patient selection: women volunteers in good health wishing to serve as egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 28 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.

Exclusion Criteria:

• Women who do not meet the inclusion criteria. Cigarette smokers. Fail random drug screening tests.