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Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Menotrophin (Drug); Follitrophin alpha (Drug); Cetrorelix (Drug); Choriongonadotropin (Drug); Progesterone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals


This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates

Clinical Details

Official title: Effect of Highly Purified Menotrophin and Recombinant Follicle Stimulating (rFSH, Follitrophin Alpha) in Subfertile Female Patients Undergoing IVF on Progesterone Serum Levels During the Follicular Phase and Their Possible Use as Predictors for the Success Rate of Ongoing Pregnancies

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

Primary outcome: Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration

Secondary outcome:

Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration

Percentage of Participants With Ongoing Pregnancy

Number of Follicles at hCG Administration

Average Follicle Diameter at hCG Administration

Number of Cumulus-oocyte Complexes Retrieved

Number of Pronuclear Oocytes

Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade

Number of Embryos Transferred

Best Quality of an Embryo Transferred

Number of Frozen Oocytes at Pronuclear Stage

Endometrial Thickness on Day of hCG Administration

Estradiol (E2) Levels on Day of hCG Administration

Percentage of Participants With Successful Embryo Transfer

Number of Days Stimulated With Gonadotrophins

Number of Ampoules of Gonadotrophins Used

Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test

Summary of Pregnancy Outcome


Minimum age: 34 Years. Maximum age: 42 Years. Gender(s): Female.


Inclusion Criteria:

- Signed informed consent

- Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF)


- Aged ≥34 and ≤42 years

- Body mass index of >18 and <28 kg/m^2

- Normal pelvic ultrasound at Screening

- No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic

sperm injection (ICSI) in the history of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not count; Clomifen cycles are no exclusion criterion)

- At least 3 consecutive ovulatory menstrual cycles of 24-35 days

- No fertility stimulating drugs at all

- Sperm of partner classified as normal according to World Health Organisation (WHO)

2010 criteria

- Clinically normal baseline haematology, clinical chemistry, and urinalysis values

- Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human

Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening

- Endocrine test results within the clinically normal limits at Screening

Exclusion Criteria:

- Presence of any clinically relevant systemic disease (e. g., insulin-dependent

diabetes mellitus)

- A history of or current endocrine disease (excluding treated hypothyreosis),

including polycystic ovary syndrome (PCOS) and hyperprolactinaemia

- A history of coagulation disorders

- Persistent ovarian cysts (>3 months)

- A history of hypersensitivity to any of the constituents of the study medication or

related compounds

- Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle

- History of severe ovarian hyperstimulation syndrome in former gonadotrophin

stimulated assisted reproductive technology (ART)-cycle

Locations and Contacts

Fertility Center Berlin, Berlin, Germany

Praxisklinik Sydow am Gendarmenmarkt, Berlin, Germany

Kinderwunschzentrum Dortmund, Dortmund, Germany

Universitätsklinikum Duesseldorf, Frauenklinik, Dusseldorf, Germany

Praxis für Kinderwunschbehandlung, Erlangen, Germany

NOVUM Zentrum, Essen, Germany

IVF Zentrum, Saar, Germany

Endokrinologikum Ulm, Ulm, Germany

Additional Information

Starting date: October 2010
Last updated: February 17, 2014

Page last updated: August 23, 2015

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