Clinical trial NCT01833858: Human Chorionic Gonadotrophin in an Antagonist Protocol
Official title: The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: * 60 women, where 30 of them will receive low dose HCG with rFSH (group 1), while the other 30 women will receive rFSH (Recombinant Follicle stimulating Hormone) with a placebo (group 2) both using the antagonist protocol as a method of induction in ICSI.
* Women in both groups will be treated with a GnRH antagonist protocol with cetrotide(cetrorelix)
* In Group 1, low dose hCG (200 IU per day) with rFSH will be given daily when at least six follicles of 12 mm will be observed and E2 levels are higher than 600 ng/l, until the day of the hCG trigger administration.
* Group 2 patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

In both groups Oocytes will be retrieved 36 h after the hCG trigger shot. All mature eggs retrieved will be fertilized with intracytoplasmic sperm injection (ICSI). Fertilization will be checked at 18 hours post insemination. Embryo quality will be assessed and embryo transfer will occur at day 3.

Eligibility 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

Primary outcomes:
measure: Number of oocytes
timeFrame: 9 months
measure: Pregnancy rate
timeFrame: 11months
Secondary outcomes:
measure: Cost of antagonist treatment
timeFrame: 9 months
measure: Spiral artery Doppler indices
timeFrame: 9 months
measure: The percentage of the perifollicular vascularity using power doppler
timeFrame: 9 months
Other outcomes:
measure: Serum level of inhibin A
timeFrame: 9 months
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: