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NCT03373149·Phase 2·INTERVENTIONAL

Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response

CetrorelixOtherUnknown

Status

Unknown

Phase

Phase 2

Enrollment

228

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Full detailed description

To date, a limited number of studies have been performed in order to assess whether the addition of GH can improve the probability of pregnancy in poor responders undergoing ovarian stimulation for IVF. Moreover, the existing studies are underpowered and, thus, inconclusive. In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Interventions

Treatment arms and agents.

DRUG

Growth hormone/HPuFSH/GnRH antagonist

Growth hormone (Somatropin, Sedico, Egypt) \[4 IU/day\] and highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) \[300 IU/day\] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.

DRUG

HPuFSH/GnRH antagonist

Highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) \[300 IU/day\] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.

Timeline

From registration to results.

  1. First posted

    Dec 14, 2017

  2. Study start

    Nov 29, 2017

  3. Primary completion

    Jul 2020

  4. Study completion

    Nov 2020

  5. Results posted

    Not reported

  6. Registry updated

    May 27, 2020

Outcomes

What the study measures.

Primary outcomes

The number of participants who achieved a clinical pregnancy in a transfer cycle

Time frame · Five weeks after embryo transfer

Secondary outcomes

The number of participants who achieved a ongoing pregnancy in a transfer cycle

Time frame · Eighteen weeks after embryo transfer

Eligibility

Who can take part.

Minimum age
35 Years
Maximum age
42 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml Exclusion Criteria: \-

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Riyadh Fertility and Reproductive Health center

Giza, Egypt

Publications

Results and literature.

PMID 23208461 ↗Eftekhar M, Aflatoonian A, Mohammadian F, Eftekhar T. Adjuvant growth hormone therapy in antagonist protocol in poor responders undergoing assisted reproductive technology. Arch Gynecol Obstet. 2013 May;287(5):1017-21. doi: 10.1007/s00404-012-2655-1. Epub 2012 Dec 4.PMID 34808697 ↗Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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More studies on Cetrorelix.

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