NCT01390207

Brief Summary

The effect of altering the timing of hCG administration on the ongoing pregnancy rate in patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH) antagonists for in vitro fertilisation (IVF).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

May 19, 2011

Last Update Submit

August 3, 2011

Conditions

hCG

Keywords

hCG triggeringpregnancyGnRH antagonist

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate.

    1 year

Secondary Outcomes (1)

  • number of MII oocytes.

    1 year

Study Arms (1)

16mm follicles

EXPERIMENTAL
Other: 16mm triggering

Interventions

16mm triggeringOTHER

Final oocyte maturation will be achieved by administration of 10.000 IU of hCG (Pregnyl®). Randomization will be into 2 groups: • Group A (early hCG group): hCG will be administrated as soon as ≥ 3 follicles ≥ 16mm were present on ultrasound.

16mm follicles

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index between 18 and 29 kg/m²¬
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
  • Treatment with IVF/ICSI
  • Embryo transfer on day 3 (1 or 2 embryos)
  • Patients can enter in the study only once

You may not qualify if:

  • Presence of endometriosis stage ≥3(AFS)
  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Need for preimplantation genetic diagnosis (PGD)
  • Azoospermia testicular sperm extraction (TESE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2011

First Posted

July 8, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-07