Human Chorionic Gonadotrophin in an Antagonist Protocol

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a source of LH (luteinizing hormone) in the late follicular phase .

This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other benefits of this regimen.

HCG might also affect endometrial function, stimulate endometrial growth and maturation and enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These results could lengthen the implantation Window.

Inhibin A is a heterodimer protein and does not begin to increase until just after the increase in oestradiol in the late follicular phase, suggesting secretion by the dominant follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine action on oocyte maturation. Moreover, it is related to follicular development and size, serving as a marker of follicular maturation after IVF cycles .However, the role of hCG supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate and more studies is needed. Thus, the objective of this trial was to investigate whether LH activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Chorionic Gonadotropin

Criteria

Inclusion Criteria:

1. Indication for ICSI treatment.

2. The presence of one or two functional ovaries.

3. Good responders to ovarian stimulation.

4. The presence of normal uterine cavity

5. Basal (day 2 or 3) serum FSH (follicle stimulating Hormone) levels ≤13 IU

6. No untreated endocrinologic disease

Exclusion Criteria:

1. Abnormal uterine cavity.

2. Basal (day 2 or 3) serum FSH levels ≥13 IU.

3. Poor responders to ovarian stimulation according to the existence of at least two of the following criteria:Advanced maternal age (above 40 years), antral follicles count <5, prior history of poor response to controlled ovarian hyperstimulation (peak E2 <500 pg/ml and/or ≤3 oocytes retrieved).

4. Untreated endocrinologic disease.

5. Azoospermia. all patients should be managed in Cairo,Egypt