Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients

Phase 2

Terminated

• Conditions: Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer
• Interventions: Drug: Somatropin

• Registration Number: NCT01298960
• Lead Sponsor: Institut Universitari Dexeus

Brief Summary

Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
• Infertility requiring IVF with or without ICSI.
• Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - < 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count < 5.
• Partner sperm.
• Presence of both ovaries and normal uterine cavity.
• PAP smear within normality in previous 3 years.
• Negative pregnancy test (serum or urine) before rFSH administration.
• Willingness of adhesion to protocol during the whole study period.
• Signed informed consent given.

Exclusion Criteria

• HIV, HCV, HBV positive serologies in women or partner.
• Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
• BMI > 32 kg/m2 or antecedent of diabetes mellitus.
• Gonadotrophin treatment within the previous 30 days.
• Availability of frozen embryos of previous IVF cycles .
• Abnormal uterine bleeding.
• Previous treatment with LH or LH effect drugs.
• Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
• Contraindication for pregnancy.
• Allergies to gonadotrophins or somatotropin.
• History of drug or alcohol abuse in the previous 5 years.
• Previous enrollment in this study or simultaneous participation in another study with drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rGH Group	Somatropin	-

Primary Outcome Measures

Name	Time	Method
Number of metaphase II oocytes retrieved	3 months after having finished recruitment

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	9 months after ovum pick-up
Adverse events due to rGH	3 months after having finished recruitment

Trial Locations

Locations (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain