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