Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT02293668

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: FSH 225IU and hMG 225IU Drug: FSH 150IU and hMG 150IU Drug: Letrozole 5mg and hMG 150IU	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Combined 450 Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.	Drug: FSH 225IU and hMG 225IU
Active Comparator: Combined 300 Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.	Drug: FSH 150IU and hMG 150IU
Active Comparator: Letrozole and hMG Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.	Drug: Letrozole 5mg and hMG 150IU

Arm

Intervention/Treatment

Active Comparator: Combined 450

Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: FSH 225IU and hMG 225IU

Active Comparator: Combined 300

Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: FSH 150IU and hMG 150IU

Active Comparator: Letrozole and hMG

Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: Letrozole 5mg and hMG 150IU

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rate [8 weeks]

Secondary Outcome Measures

Number of oocytes retrieved [4 weeks]
Number of transferable embryos [4 weeks]
Biochemical pregnancy rate [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University School of Medicine	Istanbul		Turkey	34093

Sponsors and Collaborators

Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

Responsible Party:

Ercan Bastu, Associate Professor of Obstetrics and Gynecology, Istanbul University

ClinicalTrials.gov Identifier:

NCT02293668

Other Study ID Numbers:

1001

First Posted:

Nov 18, 2014

Last Update Posted:

Jan 8, 2016

Last Verified:

Jan 1, 2016

Keywords provided by Ercan Bastu, Associate Professor of Obstetrics and Gynecology, Istanbul University

poor responders

Additional relevant MeSH terms:

Infertility

Letrozole

Study Results

No Results Posted as of Jan 8, 2016