NCT01645241

Brief Summary

The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

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

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 27, 2014

Status Verified

March 1, 2013

Enrollment Period

1.4 years

First QC Date

July 18, 2012

Last Update Submit

October 24, 2014

Conditions

INFERTILITYFertility PreservationOvulation InductionVitrificationOocyte Donation

Keywords

Ovarian stimulationLuteal phaseEgg donorsFertility preservation

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    six weeks after transfer procedure

Secondary Outcomes (1)

  • Number of Mature oocytes

    Day of oocyte retrieval

Study Arms (1)

Lutheal phase ovarian stimulation

EXPERIMENTAL

Early luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage.

Drug: gonadotropins plus GnRH antagonistsDrug: ganirelix

Interventions

gonadotropins plus GnRH antagonistsDRUG
Also known as: Ovarian stimulation
Lutheal phase ovarian stimulation
ganirelixDRUG
Also known as: the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix
Lutheal phase ovarian stimulation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal women, 18-35 years old, FSH levels \< 10 mIU/ml; AFC\> 10
  • regular cycles
  • BMI \< 28
  • signed informed consent
  • Recipients:
  • Infertile women eligible for oocytes donation
  • BMI \< 35
  • Signed informed consent form

You may not qualify if:

  • Polycystic ovarian syndrome, gonadotropins allergy
  • Recipients:
  • Women eligible for oocytes donation
  • BMI \>35
  • Uncontrolled Endocrine Pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Barcelona, Barcelona, 08037, Spain

Location

Related Publications (3)

  • Sonmezer M, Turkcuoglu I, Coskun U, Oktay K. Random-start controlled ovarian hyperstimulation for emergency fertility preservation in letrozole cycles. Fertil Steril. 2011 May;95(6):2125.e9-11. doi: 10.1016/j.fertnstert.2011.01.030. Epub 2011 Feb 3.

    PMID: 21292255BACKGROUND

  • von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-1365. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.

    PMID: 18930226BACKGROUND

  • Martinez F, Clua E, Devesa M, Rodriguez I, Arroyo G, Gonzalez C, Sole M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.

    PMID: 25154677DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Interventions

GonadotropinsOvulation Inductionganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Francisca Martínez, PhD

    Fundación Dexeus Salut de la Dona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 27, 2014

Record last verified: 2013-03

Locations

ES(1)