Low-dose GH Supplementation Increases Clinical Pregnancy Rate
|ClinicalTrials.gov Identifier: NCT02359695|
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Growth Hormone||Phase 1|
The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer.
Controlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation.
After confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached > 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.|
|Actual Study Start Date :||October 2013|
|Primary Completion Date :||December 2016|
|Study Completion Date :||May 2017|
Experimental: GH cycle
Subsequent IVF cycle, supplemented with a low dose of growth hormone.
Drug: Growth Hormone
A dose of 0.5 IU of growth hormone will be administered daily from the first day of the agonist until the day of hCG administration
Other Name: Somatotropin
- Clinical pregnancy rate [ Time Frame: 7 weeks of gestation ]Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
- Retrieved oocytes [ Time Frame: On egg retrieval day ]Total number of retrieved oocytes
- Number of obtained embryos [ Time Frame: 3 days after egg retrieval ]Total number of obtained embryos
- Embryo quality [ Time Frame: 3 days after embryo transfer ]Total number of top quality embryos per cycle
- Proportion of cycles with embryo transfer [ Time Frame: 3 days after egg retrieval ]Proportion of cycles reaching embryo transfer per initiated cycle
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359695
|Centro de Infertilidad y Reproducción Humana (CIRH)|
|Barcelona, Spain, 08017|
|Study Director:||Mario Brassesco, MD||Centro de Infertilidad y Reproducción Humana|