COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Poor ovarian responders (POR) include a significant proportion of women referred for IVF treatments (ranging from 9 to 24 %), most of whom are in late reproductive age.

In fact the live birth rate in the entire POR category is poor (about 6 % per cycle). However patients <40 years have a significantly better prognosis compared to older patients, mainly due to better oocyte quality.Attempts to improve IVF cycle outcomes for poor responders included modifying the steps of ovarian stimulation protocols , such as different luteal phase pretreatments, increasing ovarian stimulation doses, as well as addition of various supplements. So far, most of the modifications had limited success, therefore, optimal protocol for poor responders has remained elusive.

Final oocyte maturation trigger is one of the most important key success factors in assisted reproductive technologies (ARTs). Oocyte maturation refers to a release of meiotic arrest that allows oocytes to advance from prophase I to metaphase II of meiosis. Luteinizing Hormone (LH) surge by dismantling the gap junctions between granulosa cells and oocyte inhibits the flow of maturation inhibitory factors into ooplasm and causes drop in concentration of cAMP. Decreased concentration of cyclic AMP (cAMP) in turn increases concentration of Ca and maturation-promoting factor (MPF), which are essential for the resumption of meiosis in oocyte and disruption of oocyte-cumulus complex triggering follicular rupture and ovulation about 36 h the LH surge.

The aim of the study is to compare the oocyte yield , oocyte quality and the ongoing pregnancy rate between dual trigger treatment (combination of gonadotrophin-releasing hormone (GnRH) agonist and human chorionic gonadotrophin) and human chorionic gonadotrophin alone in PORs undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Chorionic Gonadotropin; Triptorelin Pamoate

Criteria

Inclusion Criteria:

1. Women with a spontaneous normal menstrual cycle and a normal uterine cavity.

2. Body mass index (BMI) < 35.

3. Age less than 45.

4. Anti-Mullerian Hormone (AMH) ≤ 1.1 ng/ ml

5. Antral Follicle Count (AFC) ≤ 7 follicles

Exclusion Criteria:

1. Comorbidities including, hypertension, Diabetes Mellitus or other endocrinopathies.

2. Surgically retrieved sperms.

3. Communicating hydrosalpinx.