NCT02892942

Brief Summary

To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian Stimulation) that dissociates E2 production from multiple follicle development. The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis IVF-ET population, the physiological E2 environment resulting from NATOS significantly improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

August 25, 2016

Last Update Submit

November 17, 2025

Conditions

Infertility

Keywords

Controlled ovarian hyperstimulationEstradiolEmbryo implantationEndometrial receptivityFertility preservation

Outcome Measures

Primary Outcomes (1)

  • Live birth obtained after IVF-ET

    Live birth defined as delivery ≥ 22 weeks of amenorrhea

    1 month post-partum

Secondary Outcomes (1)

  • Number of oocytes obtained

    At oocyte retrieval (14±8 days after start of treatment)

Other Outcomes (13)

  • Number of embryos obtained

    At day 2 of embryo development

  • Clinical pregnancy

    7 weeks of amenorrhea

  • Embryo implantation

    7 weeks of amenorrhea

  • +10 more other outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Background therapy which is the usual COH treatment: * Recombinant FSH (Gonal-F®, 225 to 450 IU/d; MerckSerono Pharmaceuticals) from day 2 of their menstrual cycle onward, * GnRH antagonist (Cetrotide®, MerckSerono Pharmaceuticals) 0.25 mg/day, S.C., starting on day 6 of Gonal-F®.

Drug: Gonal-F®Drug: Cetrotide®

NATOS Group

EXPERIMENTAL

Background therapy which is the usual COH treatment: * Recombinant FSH (Gonal-F®, 225 to 450 IU/d; MerckSerono Pharmaceuticals) from day 2 of their menstrual cycle onward, * GnRH antagonist (Cetrotide®, MerckSerono Pharmaceuticals) 0.25 mg/day, S.C., starting on day 6 of Gonal-F®. GnRH antagonist treatment (Cetrotide®, MerckSerono Pharmaceuticals) will be reinforced and patients will receive 1.5 mg/day (6 ampoules of 0.25 mg), S.C., starting on day 1 (S1) of Gonal-F® treatment until dhCG

Drug: Gonal-F®Drug: Cetrotide®

Interventions

Gonal-F®DRUG

225 to 450 IU/d; from day 2 of menstrual cycle onward

Control GroupNATOS Group
Cetrotide®DRUG

0.25 mg/day, starting on day 6 of Gonal-F®.

Control GroupNATOS Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IVF-ET candidates (excluding PGD and oocyte donor);
  • Body mass index from 18 to 30 kg/m2;
  • Non smokers;
  • Regular menstrual cycles (25-35 days);
  • Presence of both ovaries;
  • Antral follicle count (follicles measuring from 3 to 10 mm in diameter) ranging from 10 to 30 on cycle days 2 to 4;
  • Serum AMH levels ranging from 0.5 to 5.0 ng/mL;
  • Normal endometrium at ultrasound (US) and/or hysteroscopy;
  • Informed consent signed

You may not qualify if:

  • Iatrogenic ovarian insufficiency (surgery, radiotherapy, chemotherapy);
  • Uterine abnormalities as demonstrated by pelvic US and/or hysteroscopy;
  • Usual contra-indications for COH (cancer risk, blood coagulation disorders, etc)
  • Renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Antoine Béclère

Clamart, 92141, France

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfacetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • RENATO FANCHIN, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 8, 2016

Study Start

January 13, 2017

Primary Completion

February 8, 2019

Study Completion

February 8, 2019

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)