NCT02448459

Brief Summary

This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the number of oocytes retrieved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

May 14, 2015

Last Update Submit

May 19, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    20 days

Secondary Outcomes (2)

  • Number of embryos

    25 days

  • Ovarian hyperstimulation syndrome

    2 months

Study Arms (1)

COOL-COS

EXPERIMENTAL

All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation

Drug: COOL-COS

Interventions

COOL-COSDRUG

Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation. The triggering will be performed using leuprorelin 1 mg (subcutaneous).

Also known as: Friendly COS
COOL-COS

Eligibility Criteria

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

You may qualify if:

  • Women scheduled to controlled ovarian stimulation for oocyte retrieval.
  • Body mass index between 18 and 35 Kg/m2.
  • Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/L).
  • Signing an informed consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Setor de Reprodução Humana - HC-FMRP-USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (5)

  • Figueiredo JB, Nastri CO, Vieira AD, Martins WP. Clomiphene combined with gonadotropins and GnRH antagonist versus conventional controlled ovarian hyperstimulation without clomiphene in women undergoing assisted reproductive techniques: systematic review and meta-analysis. Arch Gynecol Obstet. 2013 Apr;287(4):779-90. doi: 10.1007/s00404-012-2672-0. Epub 2012 Dec 19.

    PMID: 23250342BACKGROUND

  • Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013.

    PMID: 24348019BACKGROUND

  • Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.

    PMID: 23543584BACKGROUND

  • Seko LM, Moroni RM, Leitao VM, Teixeira DM, Nastri CO, Martins WP. Melatonin supplementation during controlled ovarian stimulation for women undergoing assisted reproductive technology: systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014 Jan;101(1):154-161.e4. doi: 10.1016/j.fertnstert.2013.09.036. Epub 2013 Oct 29.

    PMID: 24182414BACKGROUND

  • Nastri CO, Teixeira DM, Moroni RM, Leitao VM, Martins WP. Ovarian hyperstimulation syndrome: pathophysiology, staging, prediction and prevention. Ultrasound Obstet Gynecol. 2015 Apr;45(4):377-93. doi: 10.1002/uog.14684. Epub 2015 Mar 1.

    PMID: 25302750BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 19, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

BR(1)