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OpenTrials
Completed

NCT Number: NCT00417157

Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH

The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.

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Key information

Conditions

Infertility Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Premature Ovarian Failure Primary Ovarian Insufficiency Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Eugonia

Athens, 11528, Greece

About this study

Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Regular menstrual cycle (21-35 days)
  • Basal FSH>12 IU/ml
  • One or more failed IVF attempts (<3 oocyte retrieved)

Exclusion criteria

  • PCOS
  • Normal responders

Treatment and study plan

recombinant FSH (Puregon, Organon, The Netherlands)

Drug

GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)

Drug

hCG (Pregnyl, Organon, The Netherlands)

Drug

Primary outcomes

  1. Live birth per started cycle

    Time frame: live birth

Secondary outcomes

  1. Biochemical pregnancy per started cycle

    Time frame: positive hCG test 14 days post oocyte retrieval

  2. Clinical pregnancy per started cycle

    Time frame: presence of fetal sac and heart beat at 7 weeks of gestation

  3. Cycle cancellation rates

    Time frame: cycles not reaching oocyte retrieval

  4. Ongoing pregnancy rates per started cycle

    Time frame: presence of fetal sac and heart beat at 12 weeks of gestation

Sponsors and collaborators

Lead sponsor

Eugonia

Other

Registry information

Official study title

Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2006
Registry last updated
Dec 16, 2013

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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