Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004146

Trial Description

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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

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Trial Acronym

PREDICT

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004146
  •   2012/11/22
  •   2010/10/07
  •   no
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Secondary IDs

  •   2010-019411-37 
  •   NCT01225835  (ClinicalTrials.gov)
  •   FE999906 CS11  (Ferring Pharmaceuticals)
  •   2010-019411-37 
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Health Condition or Problem studied

  •   Infertility
  •   N97 -  Female infertility
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Interventions/Observational Groups

  •   Drug: Menotrophin
  •   Drug: Follitrophin alpha
  •   Drug: Cetrorelix
  •   Drug: Choriongonadotropin
  •   Drug: Progesterone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- 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).

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Secondary Outcome

- 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.
- 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.
- 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.
- Average Follicle Diameter at hCG Administration; time frame: approximately day 10
- Number of Cumulus-oocyte Complexes Retrieved; time frame: approximately day 12 after study start; Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.
- Number of Pronuclear Oocytes; time frame: approximately day 13 after study start; Pronuclear oocytes are fertilized oocytes.
- 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.
- Number of Embryos Transferred; time frame: approximately day 14; Mean number of embryos transferred 2-3 days following oocyte retrieval.
- 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.
- 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.
- 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.
- Estradiol (E2) Levels on Day of hCG Administration; time frame: approximately day 10
- Percentage of Participants With Successful Embryo Transfer; time frame: approximately day 18
- 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.
- 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.
- 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.
- Summary of Pregnancy Outcome; time frame: up to 10 months; Pregnancy outcomes were reported at the optional long-term follow up visit.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/10/31
  •   120
  •   Multicenter trial
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Inclusion Criteria

  •   Female
  •   34   Years
  •   42   Years
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Additional 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

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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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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.