IVF/ICSI Protocols in Poor Responders With Growth Hormone

NCT ID: NCT01897324

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-01-31

Brief Summary

in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.

Detailed Description

Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The Long protocol

Patients in the group A received a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) which started on day 21 of preceding cycle at a dose of 0.1 mg/day. On the second day of menstruation HMG was started and this was associated with reduction of triptorelin to 0.05 mg/day. This reduced daily dose was administered until the day hCG was given. Growth hormone co-treatment was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Group Type: EXPERIMENTAL

Growth hormone (Norditropin, Novo nordisk)

Intervention Type: DRUG

The Short protocol

The short agonist protocol was started on cycle day 1 with triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. Human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) were also administered starting from days 2 to 3 of cycle. The dose was adjusted for each patient according to the diameter of the follicles detected in their follow up ultrasound. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Group Type: EXPERIMENTAL

Growth hormone (Norditropin, Novo nordisk)

Intervention Type: DRUG

The Antagonist protocol

Gonadotrophins IM daily (HMG 75 IU, Merional, IBSA)was administrated from day 2 of the cycle. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. The GnRH antagonist (Cetrotide) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.

Group Type: EXPERIMENTAL

Growth hormone (Norditropin, Novo nordisk)

Intervention Type: DRUG

The Microflare protocol

the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Group Type: EXPERIMENTAL

Growth hormone (Norditropin, Novo nordisk)

Intervention Type: DRUG

Interventions

Growth hormone (Norditropin, Novo nordisk)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

ESHRE consensus 2011,At least two of the following three features must be present:

• Advanced maternal age (≥40 years) or any other risk factor for POR;
• A previous POR (≤3 oocytes with a conventional stimulation protocol);
• An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml).

Exclusion Criteria

• female patients with causes of infertility other than poor ovarian reserve
• females suffering from congenital or acquired uterine anomalies
• females with focal uterine lesions
• females who had previous ovarian surgeries
• females with history of previous exposure to radiotherapy , or chemotherapy
• females refusing to get enrolled in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Refaat Dakhly

lecturer of obstetrics and gynecology, cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

private IVF medical center

Giza, Cairo Governorate, Egypt

Countries

Egypt

References

Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.

Reference Type: DERIVED

PMID: 26416521 (View on PubMed)

Other Identifiers

WHC2013

Identifier Type: -

Identifier Source: org_study_id