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

Status

Completed

Phase

Phase 4

Enrollment

38 participants (actual)

Sponsor

Michigan Reproductive Medicine · Other

Design

Randomized · Open label (no masking)

Countries

1 country

United States

Start

Apr 2014

Primary completion

12 Feb 2017

Completion

8 Mar 2017

First posted

24 Feb 2014 (estimated)

Last update posted

23 Mar 2018

Conditions

Egg Donation

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.

• Experimental

  Group B: Follistim and Menopur

  Group B: N=25 subjects 1. Cycle day 2 start Follistim 200 U/day up to 11 days duration. 2. Cycle day 2 start Menopur (menotropins) 75 U/day up to 11 days duration. 3. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 4. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 5. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger.

• Active comparator

  Group A: Follistim only

  Group A: N=25 subjects 1. Cycle day 2 start Follistim 250 U/day up to 11 days duration. 2. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 3. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 4. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger.

1. number of mature oocytes recovered and cryopreserved.

   Time frame · 2 weeks

   Registry description

   Immediately after egg harvest, The embyrologist performed microscopic examination of oocytes and is able to determine if the oocyte has completed meiosis 1 with the extrusion of the first polar body and has entered the second stage of meiosis. An oocyte of this developmental stage is considered mature and receptive to a sperm.

No study cites this trial.