Antagonist Protocol in Poor Responders

Female Infertility Due to Diminished Ovarian Reserve Clinical Trial

Official title:

Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195947
• Other study ID #: 72014
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Female Infertility Due to Diminished Ovarian Reserve
• Infertility
• Infertility, Female

Intervention

Drug:
• Growth Hormone
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.

Locations

Country	Name	City	State
Egypt	Kasr Al Aini	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chemical pregnancy rate		5 weeks
Other	Early miscarriage rate		Up to 12 weeks
Other	Ongoing pregnancy rate		Up to 12 weeks
Primary	Live birth rate		Up to 9 months
Secondary	Clinical pregnancy rate		Up to 5 weeks