---
title: Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle
nct_id: NCT01006954
overall_status: COMPLETED
phase: PHASE3
sponsor: Royan Institute
study_type: INTERVENTIONAL
primary_condition: Infertility
countries: Iran
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01006954.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01006954"
ct_last_update_post_date: 2018-12-19
last_seen_at: "2026-05-12T07:06:57.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01006954](https://clinicaltrials.gov/study/NCT01006954)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Royan Institute
- **Conditions:** Infertility
- **Start Date:** 2008-09
- **Completion Date:** 2010-02
- **CT.gov Last Update:** 2018-12-19

## 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

- **Minimum age:** 30 Years
- **Maximum age:** 42 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Flare Up** (ACTIVE_COMPARATOR) — Flare up protocol in poor responders for IVF/ICSI
- **Microdose GnRh** (EXPERIMENTAL) — Microflare protocol in poor responders for IVF/ICSI

## Interventions

- **Microdose GnRh** (DRUG) — Microflare protocol in poor responders for IVF/ICSI
- **Flare up** (DRUG) — Flare up protocol in poor responders for IVF/ICSI

## Primary Outcomes

- **Live birth rate** _(time frame: 12 months)_

## Secondary Outcomes

- **Cycle cancellation rates** _(time frame: 12 Months)_
- **Number of oocytes generated** _(time frame: 12 Months)_
- **Number of embryos generated** _(time frame: 12 Months)_
- **Implantation rate** _(time frame: 12 Months)_
- **Pregnancy rate** _(time frame: 12 months)_

## Locations (1)

- 1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR, Tehran, Iran

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.1- endocrinology and female infertility department, reproductive medicine research centre, royan institute, acecr|tehran||iran` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01006954*  
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