Microflare Protocol in Poor Responders

Female Infertility Due to Diminished Ovarian Reserve Clinical Trial

Official title:

Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185326
• Other study ID #: WHE062013
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2014
• Last updated: January 26, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• 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:

(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).

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Growth hormone (Norditropin, Novo nordisk)
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 el aini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rates		15 months	No