Antagonist Protocol in Poor Responders

NCT02195947 | Completed Phase 4

• 1 other identifier: 72014
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Keywords

Growth hormone; IVF/ICSI; Poor responder; Antagonist protocol

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Up to 9 months

Secondary Outcomes (1)

• Clinical pregnancy rate

  Up to 5 weeks

Other Outcomes (3)

• Chemical pregnancy rate

  5 weeks

• Early miscarriage rate

  Up to 12 weeks

• Ongoing pregnancy rate

  Up to 12 weeks

Study Arms (2)

Antagonist and Growth hormone

EXPERIMENTAL

HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. 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

Antagonist

NO INTERVENTION

HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

Interventions

Growth Hormone 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

Antagonist 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:
• dvanced maternal age (≥40 years) or any other risk factor for POR
• 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:

• 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

• Cairo University: lead

Study Sites (1)

Kasr Al Aini

Cairo, Egypt

Location

Related Publications (1)

• Bassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016 Mar;105(3):697-702. doi: 10.1016/j.fertnstert.2015.11.026. Epub 2015 Dec 13.

  PMID: 26690008 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

• Yomna A Bayoumi, 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: Dr

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

EG (1)