Clinical trial NCT01006954: Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle
Official title: Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Poor responder
Flare up
Micro dose GnRH agonist flare up
IVF/ICSI
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2009-11-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.

Detailed description: In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.

The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.

Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become \>14.

2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Eligibility criteria: Inclusion Criteria:

Poor responders (Presence of at least two of following items is necessary for inclusion to the study)

* History of Cycle Cancellation
* History of oocyte number 3 (in previous cycle)
* History of Number of antral follicle \< 5 in previous cycle
* Age≥38
* FSH\>12 on day 2 or 3
* Ovarian Volume 3 cm3

Exclusion Criteria:

* Male factor (azospermi)
* Myoma ≥6cm
* One way ovary
* Tumor or cyst \>13mm
* Age \>42

Primary outcomes:
measure: Live birth rate
timeFrame: 12 months
Secondary outcomes:
measure: Cycle cancellation rates
timeFrame: 12 Months
measure: Number of oocytes generated
timeFrame: 12 Months
measure: Number of embryos generated
timeFrame: 12 Months
measure: Implantation rate
timeFrame: 12 Months
measure: Pregnancy rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: 1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR
Study officials:
affiliation: Royan Institute
name: Tahereh Madani, MD
role: STUDY_CHAIR
affiliation: Royan Institute
name: Firoozeh Ghaffari, MD
role: STUDY_DIRECTOR
affiliation: Royan Institute
name: Tahereh Madani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghaffari F, Jahangiri N, Madani T, Khodabakhshi S, Chehrazi M. Randomized controlled trial of gonadotropin-releasing hormone agonist microdose flare-up versus flare-up among poor responders undergoing intracytoplasmic sperm injection. Int J Gynaecol Obstet. 2020 Jan;148(1):59-64. doi: 10.1002/ijgo.12988. Epub 2019 Oct 18.