IVF/ICSI Protocols in Poor Responders With Growth Hormone

Phase 4

Completed

• Conditions: Female Infertility Due to Diminished Ovarian Reserve
• Interventions: Drug: Growth hormone (Norditropin, Novo nordisk)

• Registration Number: NCT01897324
• Lead Sponsor: Woman's Health University Hospital, Egypt

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 287

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Long protocol	Growth hormone (Norditropin, Novo nordisk)	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.
The Short protocol	Growth hormone (Norditropin, Novo nordisk)	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.
The Antagonist protocol	Growth hormone (Norditropin, Novo nordisk)	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.
The Microflare protocol	Growth hormone (Norditropin, Novo nordisk)	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.

Primary Outcome Measures

Name	Time	Method
Numbers of oocytes retrieved and number of fertilized oocytes	2 years	Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.

Trial Locations

Locations (1)

private IVF medical center; 🇪🇬 Giza, Cairo, Egypt