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

Early Phase 1
Conditions
Female Infertility
Interventions
Biological: Growth Hormone (GH)
Registration Number
NCT03237117
Lead Sponsor
Competence Centre on Health Technologies
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.

Detailed Description

This study includes in total 105 infertile couples treated by assisted reproduction with oocyte donation. Seventy couples that have experienced at least two previous failures with this approach at our clinic are referred to as recurrent implantation failure (RIF) patients throughout this study. Thirty five of these couples are included in the GH-treatment protocol, while the remaining 35 couples are treated in a usual way (non-GH group). Other 35 couples, treated in the same period and undergoing their first oocyte donation attempt, are included as a positive control group.

RIF patients are randomly allocated into two groups (labeled I and II). Then 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. The positive control (non-RIF) group is created by allocating all consecutive couples undergoing their first oocyte donation attempt. This allocation started immediately after the allocation of the first RIF couple and will be terminated as soon as 35 cases are enrolled.

Ovarian stimulation of the oocyte donors is as follows: oocyte donors are stimulated with the use of a long GnRH agonist protocol and human recombinant FSH (Puregon or Gonal F). Human menopausal gonadotropin (Menopur) is added when blood LH concentration, which is repeatedly determined during ovarian stimulation, falls below 1 IU/l. Final oocyte maturation is triggered by subcutaneous injection of 250 micrograms recombinant hCG (Ovitrelle), when at least 5 follicles measure 18 mm or more. Ovarian puncture for oocyte recovery is performed 36.5 h after recombinant hCG injection.

Oocyte recipients are treated with progressively increasing doses of orally administered pure estradiol (Provames) or estradiol valerate (Progynova) after previous pituitary desensitization with a single injection of the long-acting preparation of GnRH agonist triptorelin (Decapeptyl 3,75 mg). The interval between triptorelin injection and the beginning of oral estradiol treatment is ranging between 8 and 20 days. This interval is determined individually, in each case, in view of the optimal synchronization of the recipient's endometrial development and the follicular growth of the corresponding donor.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
105
Inclusion Criteria

Not provided

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
GH groupGrowth Hormone (GH)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).
non-GH groupGrowth Hormone (GH)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.
Primary Outcome Measures
NameTimeMethod
live birth rate2010-2017

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

Pregnancy rate2010-2017

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

live delivery rate2010-2017

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

Secondary Outcome Measures
NameTimeMethod
miscarriage rate2010-2017

miscarriage rate is defined as the number of miscarriages before 20 weeks divided by the number of women with a positive pregnancy test

ongoing pregnancy rate2010-2017

ongoing pregnancy rate is the number of patients with the presence of fetal heart activity divided by the number of transfer procedures

implantation rate2010-2017

Implantation rate is the number of embryonic sacs detected on ultrasound divided by the number of embryos transferred

ongoing implantation rate2010-2017

ongoing implantation rate is calculated by dividing the number of living fetuses developing beyond 20 weeks divided by the number of embryos transferred

Trial Locations

Locations (1)

University of Granada

🇪🇸

Granada, Spain

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