NATural Ovarian Stimulation

Short name NATOS

NCTNCT02892942Other idP150947

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 129 participants (actual)
Sponsor: Assistance Publique - Hôpitaux de Paris · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
France
Start: 13 Jan 2017
Primary completion: 8 Feb 2019
Completion: 8 Feb 2019
First posted: 8 Sept 2016 (estimated)
Last update posted: 3 Apr 2026
Conditions: Infertility

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020

Ph 4
NATOS
NCT02892942
13 Jan 2017 to 8 Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Gonal-F®Drug
Cetrotide®Drug
Cetrotide®Drug

Arms2

Active comparator
Control Group
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®.
Experimental
NATOS Group
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Live birth obtained after IVF-ET
Time frame · 1 month post-partum
Registry description
Live birth defined as delivery ≥ 22 weeks of amenorrhea

Secondary outcomes(1)

Number of oocytes obtained
Time frame · At oocyte retrieval (14±8 days after start of treatment)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.