Clinical trial NCT00417157: Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH
Official title: Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Premature Ovarian Failure
Keywords: GnRH antagonist
Poor responders
Oocyte donation
Modified natural cycle
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2006-12-29
Enrollment: 135
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF treatment

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth per started cycle
timeFrame: live birth
Secondary outcomes:
measure: Biochemical pregnancy per started cycle
timeFrame: positive hCG test 14 days post oocyte retrieval
measure: Clinical pregnancy per started cycle
timeFrame: presence of fetal sac and heart beat at 7 weeks of gestation
measure: Cycle cancellation rates
timeFrame: cycles not reaching oocyte retrieval
measure: Ongoing pregnancy rates per started cycle
timeFrame: presence of fetal sac and heart beat at 12 weeks of gestation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia
Study officials:
affiliation: Eugonia
name: Tryfon Lainas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A, Devroey P. Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod. 2004 Nov;19(11):2545-9. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.