Effect of Growth Hormone on Uterine Receptivity in Women With RIF in an Oocyte Donation Program

NCT03237117 | Unknown Early Phase 1

• 1 other identifier: MarGen
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

105 infertile women are enrolled in the randomized controlled trial: 70 women with a history of RIF with donated oocytes and 35 infertile women undergoing the first oocyte donation attempt. Women receiving donated oocytes are treated with progressively increasing doses of oral estradiol followed by intravaginal progesterone after previous pituitary desensitization with GnRH agonist. 35 RIF patients are treated with GH (GH patients) while the rest 35 RIF patients (non-GH patients) and 35 first-attempt patients (positive control group) are not.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (3)

• Pregnancy rate

  Pregnancy rate is calculated as the number of patients with positive beta-hCG test divided by the number of patients in whom embryos were transferred

  2010-2017

• live birth rate

  Live birth rate is calculated as the number of babies born by the number of embryos transferred

  2010-2017

• live delivery rate

  live delivery rate is obtained by dividing the number of births with the number of transfers

  2010-2017

Secondary Outcomes (4)

• ongoing pregnancy rate

  2010-2017

• implantation rate

  2010-2017

• ongoing implantation rate

  2010-2017

• miscarriage rate

  2010-2017

Study Arms (3)

GH group

EXPERIMENTAL

35 women with a history of RIF with donated oocytes. For receiving donated oocytes, the women are treated with progressively increasing doses of oral estradiol followed by intravaginal progesterone after previous pituitary desensitization with GnRH agonist. Additionally, these patients are co-treated with growth hormone (GH).

Biological: Growth Hormone (GH)

non-GH group

ACTIVE COMPARATOR

35 women with a history of RIF with donated oocytes. For receiving donated oocytes, the women are treated with progressively increasing doses of oral estradiol followed by intravaginal progesterone after previous pituitary desensitization with GnRH agonist. The treatment protocol is identical to the GH group, only that no GH is added.

Biological: Growth Hormone (GH)

positive control group

NO INTERVENTION

35 infertile women undergoing their first oocyte donation attempt are included as a positive control group. Women receiving donated oocytes are treated with progressively increasing doses of oral estradiol followed by intravaginal progesterone after previous pituitary desensitization with GnRH agonist. The treatment protocol is identical to the non-GH group, with no GH added.

Interventions

Growth Hormone (GH) BIOLOGICAL

to evaluate the effect of GH administration in the donated oocyte recipient program among women with RIF (repeated implantation failure)

GH group; non-GH group

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age below 51 years
• or more previous implantation failures in oocyte donation program
• voluntary participation
• age up to 25 year
• healthy
• voluntary participation

You may not qualify if:

• cancellation of the treatment
• no wish to participate any longer

Sponsors & Collaborators

• Competence Centre on Health Technologies: lead
• Universidad de Granada: collaborator

Study Sites (1)

University of Granada

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Signe Altmäe, PhD

CONTACT

+34 693730222; signealtmae@ugr.es

Nicolas Mendoza, MD, PhD

CONTACT

+34 653673769; nicomendoza@telefonica.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The assignments are concealed in sealed opaque envelopes until the time of enrollment: group I (GH patients) and group II (non-GH patients). All injections are performed by an independent nurse who is informed by the trial coordinator of each woman´s number and the treatment allocation. Consequently, both the clinician and the patients are blinded as to the treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: 105 infertile women are enrolled in the randomized controlled trial: 70 women are with a history of RIF with donated oocytes and 35 infertile women undergoe the first oocyte donation attempt. 35 RIF patients are treated with GH (GH patients, study group) while the rest 35 RIF patients (non-GH patients, negative control group) and 35 first-attempt patients (positive control group) are not.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: January 1, 2010
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)