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Type of Gonadotropin and Embryo Kinetics of Development (PEM-ESD)

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ClinicalTrials.gov Identifier: NCT02402192
Recruitment Status : Unknown
Verified March 2015 by Juan A Garcia-Velasco, IVI Madrid.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid

Brief Summary:
The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.

Condition or disease Intervention/treatment Phase
Infertility Drug: Corifollitropin alfa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development
Study Start Date : April 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: Corifollitropin alfa
Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
Drug: Corifollitropin alfa
Other Name: Elonva

Active Comparator: recombinant FSH
Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
Drug: Corifollitropin alfa
Other Name: Elonva

Active Comparator: HP- hMG
Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
Drug: Corifollitropin alfa
Other Name: Elonva




Primary Outcome Measures :
  1. T5 defined as the time that embryo needs to reach a 5-cell stage. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Length of stimulation (days) [ Time Frame: a month ]
  2. Total dose of gonadotropins (IU) [ Time Frame: A month ]
  3. Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation [ Time Frame: A month ]
  4. Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation [ Time Frame: A month ]
  5. Levels of progesterone (ng/ml) [ Time Frame: A month ]
  6. Fertilization rate [ Time Frame: A month ]
  7. Number of embryos transferred and cryopreserved [ Time Frame: A month ]
  8. Pregnancy rate [ Time Frame: A month ]
  9. Implantation rate [ Time Frame: A monthe ]
  10. Miscarriage rate [ Time Frame: A month ]
  11. Cancellation rate per cycle initiated [ Time Frame: A month ]
  12. Ovarian hyperstimulation syndrome rate [ Time Frame: A month ]
  13. Timings of cellular divisions [ Time Frame: A month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women <38 years old
  • Weight <60 kg
  • Own oocytes
  • Patients have to provide signed informed consent

Exclusion Criteria:

  • Oocyte donors
  • Vitrified oocytes
  • Severe male factor (<1 million spz/ml)
  • Weight >60 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402192


Contacts
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Contact: Carmen Bou, Graduate 911802900 Carmen.Bou@ivi.es
Contact: Maria Cruz, PhD 911802900 Maria.Cruz@ivi.es

Sponsors and Collaborators
IVI Madrid

Publications of Results:
Other Publications:
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Responsible Party: Juan A Garcia-Velasco, PhD MD, IVI Madrid
ClinicalTrials.gov Identifier: NCT02402192    
Other Study ID Numbers: 1411-MAD-079-CB
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Juan A Garcia-Velasco, IVI Madrid:
corifollitropin alfa
recombinant FSH
HP-hMG
time-lapse
kinetics of development
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female