---
title: Step Down FSH Approach and Late Follicular Phase in Progesterone Level
nct_id: NCT03356964
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: ART Fertility Clinics LLC
study_type: INTERVENTIONAL
primary_condition: Progesterone Resistance
countries: United Arab Emirates
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03356964.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03356964"
ct_last_update_post_date: 2020-09-09
last_seen_at: "2026-05-12T06:36:16.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Step Down FSH Approach and Late Follicular Phase in Progesterone Level

**Official Title:** Impact of Step-down Approach During Late Follicular Phase in Recombinant FSH-stimulation Dosage for IVF on Progesterone Level on the Day of Final Oocyte Maturation

**NCT ID:** [NCT03356964](https://clinicaltrials.gov/study/NCT03356964)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 127
- **Lead Sponsor:** ART Fertility Clinics LLC
- **Collaborators:** Merck Serono International SA
- **Conditions:** Progesterone Resistance
- **Start Date:** 2017-11-23
- **Completion Date:** 2020-08-31
- **CT.gov Last Update:** 2020-09-09

## Brief Summary

Step-down approach and late follicular phase progesterone level

## Detailed Description

The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of 12.5IU.

It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Primary / secondary infertility with the indication for IVF/ICSI
* Patients age 18 - 40 years
* 60 kg up to and including 90 kg
* BMI of 18-32 kg/m2
* Menstrual cycle length of 24-35 days

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion criteria:

* presence or history of an endocrine abnormality
* abnormal outcome of blood biochemistry or hematology
* relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment
* history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)
* History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)
* ovarian reserve parameter, indicating the risk of poor ovarian response (AFC \< 5 and AMH \< 0,5ng/ml) (14)
```

## Arms

- **Control group** (ACTIVE_COMPARATOR) — Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (13). The stimulation dosage will remain unchanged until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).
- **Study group** (EXPERIMENTAL) — Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (LaMarca et al.). As soon as ≥ 3 follicle of a size of 14mm are seen, the stimulation dosage will be reduced daily by 12.5 IU recFSH until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).

## Interventions

- **follicle stimulating hormone** (DRUG) — Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged

## Primary Outcomes

- **Impact of dose reduction in recFSH for IVF on the progesterone level.** _(time frame: 1year and 6 months)_ — Whether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels.

## Locations (1)

- IVI Middle East Fertilty Clinic, Abu Dhabi, United Arab Emirates

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — 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)_
- `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.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ivi middle east fertilty clinic|abu dhabi||united arab emirates` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03356964.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03356964*  
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