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Completed

NCT Number: NCT01703728

Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

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Key information

Age range

18 year–36 year

Sex eligibility

Female

Study type

Observational

Primary location

Cabinet Mirabeau Roy René (there may be other sites in this country), Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS.
  • Absence of infertility treatment during the last 3 months before enrolment.
  • Age: from 18 to 36 years old.
  • BMI between 18 and 30 kg / m².
  • Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities.
  • Male or female infertility.
  • Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or antagonist.
  • Normal ovarian reserve according to physician habitual evaluation.
  • Consent to participate of the no-interventional study and signature of the patients' information sheet.

Exclusion criteria

  • Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation.
  • Known endometriosis grade III or IV.
  • Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician.
  • Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD).
  • Smoking over than 10 cigarettes / day.´
  • Participation in an interventional study at the time of inclusion.
  • Known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result in ovarian reserve test (AMH < 1 ng/ml with Immunotech equipment or AMH<0.7 ng/ml with DSL equipment).

Treatment and study plan

Highly purified menotropin (HP- hMG) treatment

Other

No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice

Primary outcomes

  1. Incidence of moderate/severe OHSS

    Time frame: 2-12 weeks

Secondary outcomes

  1. Incidence of each form of OHSS: mild, moderate and severe

    Time frame: 2-13 weeks

  2. Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol

    Time frame: 2-13 weeks

  3. OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification

    Time frame: 2-13 weeks

  4. Patients' baseline characteristics

    Time frame: At baseline

  5. Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation

    Time frame: Up to 3 weeks

  6. Description and duration of hospitalisation, treatments prescribed

    Time frame: 2-13 weeks

  7. Frequency and reasons for stimulation arrest and no embryo transfer decision

    Time frame: 2-4 weeks

  8. Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos

    Time frame: 2-3 weeks

  9. Description of serious and not serious adverse events

    Time frame: 2-13 weeks

  10. Description of patient's compliance to the prescribed treatment

    Time frame: 2-4 weeks

  11. Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate

    Time frame: 4-13 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Acronym: SHOview

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2012
Registry last updated
May 31, 2017

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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