Microflare Protocol in Poor Responders

NCT02185326 | Completed Phase 4 DMC

• 1 other identifier: WHE062013
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Keywords

Poor responders; Poor ovarian response; IVF/ICSI; Microflare protocol; Growth hormone; Oral contraceptive pills

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rates

  15 months

Study Arms (2)

Microflare and growth hormone

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)

Microflare protocol alone

NO INTERVENTION

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

Interventions

Growth hormone (Norditropin, Novo nordisk) DRUG

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.

Also known as: Norditropin, Novo nordisk

Microflare and growth hormone

Eligibility Criteria

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

You may qualify if:

• females fulfilling the criteria of the ESHRE consensus 2011:
• At least two of the following three features must be present:
• (i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

You may not qualify if:

• women who suffer from any other cause of infertility other than poor ovarian reserve
• refusal of the patient to consent for using her data in the study.

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

• Bayoumi YA, Dakhly DM, Bassiouny YA, Hashish NM. Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response. Int J Gynaecol Obstet. 2015 Dec;131(3):305-8. doi: 10.1016/j.ijgo.2015.05.034. Epub 2015 Aug 23.

  PMID: 26381201 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

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

EG (1)