Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of study is to compare the effectiveness of the Day-5 fixed administration of GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation in Chinese women with predicted high ovarian response, and the hypotheses is that the number of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Qing Reproducive and Genetic Institute
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Follicle Stimulating Hormone; Ganirelix; Hormone Antagonists; Triptorelin Pamoate

Criteria

Inclusion Criteria:

1. Have an indication for COS and IVF/ICSI;

2. be <35 years old;

3. have a BMI of 18-25kg/m2;

4. have a regular menstruation with a range of 24-35 days;

5. fulfill one of these three criteria as follow:

• the number of oocytes retrieved>15 in previous COS cycle;

• Serum AMH (examined on the menstrual cycle day 2)>3.52ng/ml;

• antral follicle count (AFC) (examined by ultrasonic on the menstrual cycle day 2)>16

6. have willingness to give informed consent

Exclusion Criteria:

1. Presence of unilateral ovary absence;

2. Any difficulty on oocyte pick-up with abnormal condition of ovary and pelvic cavity;

3. Women have any clinically relevant pathology could impair embryo implantation or pregnancy continuation (uterine malformation, intermural uterine fibroids>3cm, intrauterine adhesion,etc);

4. Women with polycystic ovary syndrome (PCOS) diagnosed by Rotterdam consensus criterion(Rotterdam, 2004)

5. Other known abnormal ovulation disorders (including but not limited to adrenal gland disease, thyroid disease and hyperprolactinemia);

6. A history of recurrent miscarriage or previous IVF cycles failure>2;

7. A history of ovarian hypo-response in previous ovarian stimulation;

8. Women with other clinical/socio-economic factors precluding the completion of the study at the discretion of the investigator.