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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name PREDICT

NCTNCT01225835 (opens ClinicalTrials.gov in a new tab)Other idFE999906 CS11Other id2010-019411-37
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
124 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Oct 2010
Primary completion
Jan 2013
Completion
Jun 2013
First posted
21 Oct 2010 (estimated)
Last update posted
14 Mar 2014 (estimated)
Conditions
Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 4

    PREDICT

    NCT01225835

    Oct 2010 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • MenotrophinDrug
  • Follitrophin alphaDrug
  • CetrorelixDrug
  • ChoriongonadotropinDrug
  • ProgesteroneDrug

Arms2

  • Experimental

    Menotrophin

    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. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.

  • Active comparator

    Follitrophin Alpha

    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. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · approximately day 10

    Registry description

    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(17)

  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)

    Registry description

    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)

    Registry description

    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

    Registry description

    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

    Registry description

    Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.

  6. Number of Pronuclear Oocytes

    Time frame · approximately day 13 after study start

    Registry description

    Pronuclear oocytes are fertilized oocytes.

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

    Time frame · approximately day 13

    Registry description

    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

    Registry description

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

  9. Best Quality of an Embryo Transferred

    Time frame · approximately day 14

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· approximately day 10

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

GroupValue (ng/ml)Spread
Menotrophin0.690.34
Menotrophin: Stratum Age <39 Yrs0.720.35
Menotrophin: Stratum Age >=39 Yrs0.540.25
Follitrophin Alpha0.890.41
Follitrophin Alpha: Stratum Age <39 Yrs0.920.43
Follitrophin Alpha: Stratum Age >=39 Yrs0.800.28
Secondary and other outcome results(7)
Secondary outcomeNumber· Day 7, approximately Day 10 (hCG Administration)

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

GroupValue (Youden's index)
All Participants0.5189
Secondary outcomeNumber· approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)

Percentage of Participants With Ongoing Pregnancy

GroupValue (percentage of participants)
Menotrophin29.2
Follitrophin Alpha31.0
Secondary outcomeMean· approximately day 10

Number of Follicles at hCG Administration

GroupValue (follicles)Spread
Menotrophin8.74.7
Follitrophin Alpha10.54.1
Secondary outcomeMean· approximately day 10

Average Follicle Diameter at hCG Administration

GroupValue (mm)Spread
Menotrophin17.61.8
Follitrophin Alpha18.11.2
Secondary outcomeMean· approximately day 12 after study start

Number of Cumulus-oocyte Complexes Retrieved

GroupValue (oocytes)Spread
Menotrophin6.84.2
Follitrophin Alpha10.04.6
Secondary outcomeMean· approximately day 13 after study start

Number of Pronuclear Oocytes

GroupValue (oocytes)Spread
Menotrophin3.72.8
Follitrophin Alpha5.93.7
Secondary outcomeNumber· approximately day 13

Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade

GroupValue (participants)
Menotrophin11
Follitrophin Alpha17

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
MenotrophinMenotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.–2 / 6243 / 62
Follitrophin AlphaFollitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.–0 / 6245 / 62

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 34 Years up to 42 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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