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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00417157
Enrollment
135
Registered
2006-12-29
Start date
2007-01-31
Completion date
2012-12-31
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Premature Ovarian Failure

Keywords

GnRH antagonist, Poor responders, Oocyte donation, Modified natural cycle

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.

Interventions

DRUGrecombinant FSH (Puregon, Organon, The Netherlands)
DRUGGnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)
DRUGhCG (Pregnyl, Organon, The Netherlands)

Sponsors

Eugonia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Live birth per started cyclelive birth

Secondary

MeasureTime frame
Biochemical pregnancy per started cyclepositive hCG test 14 days post oocyte retrieval
Clinical pregnancy per started cyclepresence of fetal sac and heart beat at 7 weeks of gestation
Cycle cancellation ratescycles not reaching oocyte retrieval
Ongoing pregnancy rates per started cyclepresence of fetal sac and heart beat at 12 weeks of gestation

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026