Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI

NCT02766764 | Unknown Phase 4

• 1 other identifier: DHEA 4
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

Brief Summary

Two hundred and thirty women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive DHEA 25 mg (DHEA 25mg, Natrol , USA) t.d.s for 12 weeks before starting IVF/ICSI cycle in addition to Growth hormone (GH; Somatotropin, Sedico, Egypt) 4 IU on day 6 of human menopausal gonadotropin (hMG) stimulation in a daily dose of 2.5 mg subcutaneous (sc) until the day of human chorionic gonadotropin (hCG) triggering Group 2 will receive an oral placebo t.d.s. daily for 12 weeks before ICSI in addition to a sc placebo similar to GH daily from day 6 of stimulation until the day of hCG trigger.

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy

  Ongoing pregnancy will be defined as the confirmation of fetal heart pulsations using trans-vaginal ultrasound 12 weeks after embryo transfer.

  12 weeks after embryo transfer

Study Arms (2)

Study group

ACTIVE COMPARATOR

Women will receive oral DHEA 25 mg t.d.s daily for 12 weeks before ICSI in addition to daily GH injections from day 6 of hMG administration until the day of hCG administration.

Drug: DHEA; Drug: Growth hormone

Placebo group

PLACEBO COMPARATOR

Women will receive an oral placebo similar to DHEA t.d.s daily for 12 weeks before ICSI in addition to daily placebo injections similar to GH from day 6 of hMG administration until the day of hCG administration.

Drug: Placebo 1; Drug: Placebo 2

Interventions

DHEA DRUG

Women will receive oral DHEA 25 mg t.d.s. for 12 weeks before ICSI.

Study group

Growth hormone DRUG

Women will receive GH subcutaneous injections daily from day 6 of hMG administration until the day of hCG administration.

Study group

Placebo 1 DRUG

Women will receive an oral placebo similar to DHEA t.d.s for 12 weeks before ICSI

Placebo group

Placebo 2 DRUG

Women will receive subcutaneous placebo injections similar to GH daily starting from day 6 of hMG injections until the day of hCG injection

Placebo group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing ICSI with expected poor ovarian response according to the Bologna criteria

You may not qualify if:

• Body mass index \>35 Kg/m2.
• Women with a single ovary.
• Allergy to DHEA or GH.
• Diabetic women on insulin as insulin lowers DHEA levels and might reduce its effectiveness

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university hospitals

Cairo, Egypt

RECRUITING

Dar AlTeb subfertility centre

Cairo, Egypt

RECRUITING

Related Publications (4)

• Kotb MM, Hassan AM, AwadAllah AM. Does dehydroepiandrosterone improve pregnancy rate in women undergoing IVF/ICSI with expected poor ovarian response according to the Bologna criteria? A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 May;200:11-5. doi: 10.1016/j.ejogrb.2016.02.009. Epub 2016 Feb 21.

  PMID: 26963897 BACKGROUND

• Bassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016 Mar;105(3):697-702. doi: 10.1016/j.fertnstert.2015.11.026. Epub 2015 Dec 13.

  PMID: 26690008 BACKGROUND

• Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.

  PMID: 26416521 BACKGROUND

• Bayoumi YA, Dakhly DM, Bassiouny YA, Hashish NM. Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response. Int J Gynaecol Obstet. 2015 Dec;131(3):305-8. doi: 10.1016/j.ijgo.2015.05.034. Epub 2015 Aug 23.

  PMID: 26381201 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone; Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and Obstetrics

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)