NCT02625532

Brief Summary

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

November 9, 2015

Last Update Submit

August 27, 2018

Conditions

Reproductive Techniques, Assisted

Keywords

Controlled Ovarian stimulationFollicular phaseLuteal phaseReproductive Techniques, Assisted

Outcome Measures

Primary Outcomes (1)

  • number of oocytes in metaphase II obtained

    number of oocytes in metaphase II obtained by follicular puncture

    Through study completion, average 2 weeks

Secondary Outcomes (6)

  • number of oocytes cumulus complexes

    Through study completion, average 2 weeks

  • duration of stimulation (days)

    Through study completion, average 2 weeks

  • cycle cancellation rate

    Through study completion, average 2 weeks

  • Luteinizing hormone levels following administration of agonist for final oocyte maturation

    Through study completion, average 2 weeks

  • occurrence of side effects

    Through study completion, average 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Follicular phase

ACTIVE COMPARATOR

Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle

Procedure: Follicular phase

Luteal phase

EXPERIMENTAL

Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test

Procedure: Luteal phase

Interventions

Follicular phasePROCEDURE

Controlled ovarian stimulation starts on day 2-3 of the menstrual cycle with recombinant recombinant FSH + LH, adding cetrorelix when the follicles reach 14 mm size and ovarian maturation with triptorelin acetate

Also known as: Ovarian stimulation starts during the follicular phase
Follicular phase
Luteal phasePROCEDURE

Controlled ovarian stimulation is started between 3rd and 5th day after the first LH positive urine test, adding cetrorelix when follicles reached 14 mm size and ovarian maturation with triptorelin acetate

Also known as: Ovarian stimulation starts during the luteal phase
Luteal phase

Eligibility Criteria

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

You may qualify if:

  • Patient Bologna meets the criteria to be diagnosed as low responder
  • Age under 41 years
  • Regular menstrual cycles between 21 and 35 days
  • Indication of in vitro fertilization
  • Indication of start stimulation with 300 IU of FSH
  • Presence of both ovaries
  • Ability to participate and comply with the study protocol
  • Having signed the written consent form

You may not qualify if:

  • Presence of follicles larger than 10 mm in the randomization visit
  • Endometriosis III / IV
  • Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome...
  • Concurrent participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Related Publications (1)

  • Llacer J, Moliner B, Luque L, Bernabeu A, Lledo B, Castillo JC, Guerrero J, Ten J, Bernabeu R. Luteal phase stimulation versus follicular phase stimulation in poor ovarian responders: results of a randomized controlled trial. Reprod Biol Endocrinol. 2020 Feb 7;18(1):9. doi: 10.1186/s12958-020-00570-7.

    PMID: 32033610DERIVED

MeSH Terms

Conditions

Helping Behavior

Interventions

Follicular PhaseLuteal Phase

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Menstrual CycleReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Joaquín Llácer

    Instituto Bernabeu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu

Study Record Dates

First Submitted

November 9, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

ES(1)