Human Chorionic Gonadotrophin in an Antagonist Protocol

NCT01833858 | Completed Phase 2

• 1 other identifier: Protocol100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Number of oocytes

  9 months

• Pregnancy rate

  11months

Secondary Outcomes (3)

• Cost of antagonist treatment

  9 months

• Spiral artery Doppler indices

  9 months

• The percentage of the perifollicular vascularity using power doppler

  9 months

Other Outcomes (1)

• Serum level of inhibin A

  9 months

Study Arms (2)

Placebo +rFSH

PLACEBO COMPARATOR

Patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

Drug: Placebo

Low dose HCG with rFSH

ACTIVE COMPARATOR

Low dose hCG (200 IU per day) will be given daily with rFSH 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

Drug: Low dose HCG

Interventions

Low dose HCG DRUG

Low dose hCG (200 IU per day) will be given daily when at least six follicles of 12 mm will be observed and E2 (Estradiol) levels are higher than 600 ng/l, until the day of the HCG trigger administration.

Also known as: Human chorionic gonadotrophin

Low dose HCG with rFSH

Placebo DRUG

Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

Also known as: saline 0.9%

Placebo +rFSH

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Indication for ICSI treatment.
• The presence of one or two functional ovaries.
• Good responders to ovarian stimulation.
• The presence of normal uterine cavity
• Basal (day 2 or 3) serum FSH (follicle stimulating Hormone) levels ≤13 IU
• No untreated endocrinologic disease

You may not qualify if:

• Abnormal uterine cavity.
• Basal (day 2 or 3) serum FSH levels ≥13 IU.
• 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).
• Untreated endocrinologic disease.
• Azoospermia. all patients should be managed in Cairo,Egypt

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 17, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

EG (1)