Clinical trial NCT01225835: Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2010-10-21
Enrollment: 124
Sex: FEMALE
Minimum age (years): 34
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
* 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

Primary outcomes:
measure: Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
timeFrame: approximately day 10
Secondary outcomes:
measure: Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration
timeFrame: Day 7, approximately Day 10 (hCG Administration)
measure: Percentage of Participants With Ongoing Pregnancy
timeFrame: approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)
measure: Number of Follicles at hCG Administration
timeFrame: approximately day 10
measure: Average Follicle Diameter at hCG Administration
timeFrame: approximately day 10
measure: Number of Cumulus-oocyte Complexes Retrieved
timeFrame: approximately day 12 after study start
measure: Number of Pronuclear Oocytes
timeFrame: approximately day 13 after study start
measure: Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade
timeFrame: approximately day 13
measure: Number of Embryos Transferred
timeFrame: approximately day 14
measure: Best Quality of an Embryo Transferred
timeFrame: approximately day 14
measure: Number of Frozen Oocytes at Pronuclear Stage
timeFrame: approximately day 14
measure: Endometrial Thickness on Day of hCG Administration
timeFrame: approximately day 10
measure: Estradiol (E2) Levels on Day of hCG Administration
timeFrame: approximately day 10
measure: Percentage of Participants With Successful Embryo Transfer
timeFrame: approximately day 18
measure: Number of Days Stimulated With Gonadotrophins
timeFrame: Day 1 up to Day 12
measure: Number of Ampoules of Gonadotrophins Used
timeFrame: Day 1 up to Day 12
measure: Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test
timeFrame: approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test
measure: Summary of Pregnancy Outcome
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Fertility Center Berlin
city: Berlin
country: Germany
facility: Praxisklinik Sydow am Gendarmenmarkt
city: Dortmund
country: Germany
facility: Kinderwunschzentrum Dortmund
city: Dusseldorf
country: Germany
facility: Universitätsklinikum Duesseldorf, Frauenklinik
city: Erlangen
country: Germany
facility: Praxis für Kinderwunschbehandlung
city: Essen
country: Germany
facility: NOVUM Zentrum
city: Saar
country: Germany
facility: IVF Zentrum
city: Ulm
country: Germany
facility: Endokrinologikum Ulm
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: