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

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.

Conditions

• Egg Donation

Interventions

DRUG

Follistim

Follicle stimulating hormone promotes recruitment of follicles for ovulation.

DRUG

Ganirelix

GnRH antagonist preventing a problematic risk of premature LH surge during ovulation induction therapy.

DRUG

Menotropins

Combination of follicle stimulating hormone and Luteinizing hormone activity promotes recruitment of follicles for ovulation. Absence or presence of this medication is the difference being tested between the two arms of the study.

DRUG

Leuprolide

Promotes endogenous LH surge signaling oocyte maturation followed by ovulation. This controls timing for oocyte collection.

PROCEDURE

Transvaginal ultrasound guided needle aspiration of oocytes

Sponsors & Collaborators

• Michigan Reproductive Medicine

  lead OTHER

Principal Investigators

• Michael S Mersol-Barg, MD · Michigan Reproductive Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

28 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2017-02-12

Completion

2017-03-08

Countries

• United States

Study Locations