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Completed

NCT Number: NCT01225835

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

34 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fertility Center Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menotrophin

Drug

Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.

Other names: Menogon® HP

Follitrophin alpha

Drug

Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.

Other names: Gonal-f®

Cetrorelix

Drug

Participants self-inject subcutaneously Cetrorelix in the morning at a daily dose of 0.25 mg/day from Day 5 of gonadotrophin administration on and continue throughout the period of gonadotrophin treatment up to day 12 as a maximum. The last dose of Cetrorelix is given on the day of ovulation induction.

Other names: Cetrotide®, GnRH antagonist

Choriongonadotropin

Drug

10,000 IU administered by the Investigator or designated personnel in the evening of the day on which the hCG criterion is met (no later than Day 13). The criterion for hCG administration is three follicles >+17 mm diameter as shown by pelvic ultrasound examination.

Other names: Brevactid®, human chorionic gonadotropin (hCG)

Progesterone

Drug

Vaginal gel progesterone is used once daily at a dose of 90 mg for a period of 30 days starting on the day of oocyte retrieval (approximately Day 14).

Other names: Crinone®, intravaginal progesterone

Primary outcomes

  1. Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration

    Time frame: approximately day 10

    Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years).

Secondary outcomes

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

    Time frame: Day 7, approximately Day 10 (hCG Administration)

    The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect.

  2. Percentage of Participants With Ongoing Pregnancy

    Time frame: approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)

    Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test.

  3. Number of Follicles at hCG Administration

    Time frame: approximately day 10

    Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration.

  4. Average Follicle Diameter at hCG Administration

    Time frame: approximately day 10

  5. Number of Cumulus-oocyte Complexes Retrieved

    Time frame: approximately day 12 after study start

    Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.

  6. Number of Pronuclear Oocytes

    Time frame: approximately day 13 after study start

    Pronuclear oocytes are fertilized oocytes.

  7. Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade

    Time frame: approximately day 13

    The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.

    Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once.

  8. Number of Embryos Transferred

    Time frame: approximately day 14

    Mean number of embryos transferred 2-3 days following oocyte retrieval.

  9. Best Quality of an Embryo Transferred

    Time frame: approximately day 14

    Embryo quality was measured by the following grades:

    • Grade 1: Evenly sized cells, regular cleavage, no fragmentation
    • Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation
    • Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation
    • Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell
    • Grade 4: Extensive fragmentation, only 1 cell intact
    • Grade 5: Totally fragmented, no viable cells.

    Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable.

  10. Number of Frozen Oocytes at Pronuclear Stage

    Time frame: approximately day 14

    No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen.

  11. Endometrial Thickness on Day of hCG Administration

    Time frame: approximately day 10

    Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration.

  12. Estradiol (E2) Levels on Day of hCG Administration

    Time frame: approximately day 10

  13. Percentage of Participants With Successful Embryo Transfer

    Time frame: approximately day 18

  14. Number of Days Stimulated With Gonadotrophins

    Time frame: Day 1 up to Day 12

    Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study.

  15. Number of Ampoules of Gonadotrophins Used

    Time frame: Day 1 up to Day 12

    Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha.

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

    Time frame: approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test

    A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy.

  17. Summary of Pregnancy Outcome

    Time frame: up to 10 months

    Pregnancy outcomes were reported at the optional long-term follow up visit.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring Arzneimittel GmbH

Registry information

Official study 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

Acronym: PREDICT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2010
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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