Centro de Infertilidad y Reproducción Humana (CIRH)
Barcelona, 08017, Spain
NCT Number: NCT02359695
The objective of this study is to assess whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.
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Notify Me18 year–50 year
Female
Interventional
Phase 1
Barcelona, 08017, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Somatotropin
Time frame: 7 weeks of gestation
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
Time frame: On egg retrieval day
Total number of retrieved oocytes
Time frame: 3 days after egg retrieval
Total number of obtained embryos
Time frame: 3 days after embryo transfer
Total number of top quality embryos per cycle
Time frame: 3 days after egg retrieval
Proportion of cycles reaching embryo transfer per initiated cycle
Centro de Infertilidad y Reproducción Humana
Other
Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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