IVF/ICSI Protocols in Poor Responders With Growth Hormone

NCT01897324 | Completed Phase 4 DMC

• 1 other identifier: WHC2013
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Keywords

Poor Ovarian Response; Poor Responders; IVF/ICSI; Growth Hormone

Outcome Measures

Primary Outcomes (1)

• Numbers of oocytes retrieved and number of fertilized oocytes

  Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.

  2 years

Study Arms (4)

The Long protocol

EXPERIMENTAL

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.

Drug: Growth hormone (Norditropin, Novo nordisk)

The Short protocol

EXPERIMENTAL

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.

Drug: Growth hormone (Norditropin, Novo nordisk)

The Antagonist protocol

EXPERIMENTAL

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.

Drug: Growth hormone (Norditropin, Novo nordisk)

The Microflare protocol

EXPERIMENTAL

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.

Drug: Growth hormone (Norditropin, Novo nordisk)

Interventions

Growth hormone (Norditropin, Novo nordisk) DRUG

The Antagonist protocol; The Long protocol; The Microflare protocol; The Short protocol

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

private IVF medical center

Giza, Cairo Governorate, 12311, Egypt

Location

Related Publications (1)

• 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.

  PMID: 26416521 DERIVED

MeSH Terms

Interventions

Growth Hormone; Human Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dina M Dakhly, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology, cairo university

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

EG (1)