---
title: GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)
nct_id: NCT01100333
overall_status: COMPLETED
sponsor: Merck KGaA, Darmstadt, Germany
study_type: OBSERVATIONAL
primary_condition: Infertility
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01100333.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01100333"
ct_last_update_post_date: 2014-07-31
last_seen_at: "2026-05-12T06:42:18.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)

**Official Title:** Observational Study GONAL-f® Consort

**NCT ID:** [NCT01100333](https://clinicaltrials.gov/study/NCT01100333)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 2552
- **Lead Sponsor:** Merck KGaA, Darmstadt, Germany
- **Conditions:** Infertility
- **Start Date:** 2008-04
- **Completion Date:** 2011-07
- **CT.gov Last Update:** 2014-07-31

## Brief Summary

This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.

## Detailed Description

Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.

OBJECTIVES

Primary Objective:

* To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator

## Eligibility

- **Maximum age:** 35 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication
* Subjects below 35 years of age
* Subjects who have a Body mass index below 30
* Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol
```

## Interventions

- **Recombinant human follicle stimulating hormone (r-hFSH)** (DRUG) — Recombinant hFSH prescribed according to prescriber's judgement

## Primary Outcomes

- **Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator** _(time frame: 6 month)_

## Secondary Outcomes

- **Efficacy parameters** _(time frame: 6 month)_

## Locations (1)

- Universitätsmedizin Charitè Berlin, Schumann Straße 20/21, Berlin, State of Berlin, Germany

## Recent Field Changes (last 30 days)

- `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.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universitätsmedizin charitè berlin, schumann straße 20/21|berlin|state of berlin|germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01100333.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01100333*  
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