NCT07323329

Brief Summary

The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder. The main question it aims to answer is: Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started Oct 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Oct 2025Nov 2026

Study Start

First participant enrolled

October 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2026

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 17, 2025

Last Update Submit

December 31, 2025

Conditions

InfertilityInfertility (IVF Patients)

Keywords

Growth hormoneInfertilityIVF patientsOvarian reserve

Outcome Measures

Primary Outcomes (1)

  • The number of mature oocyte

    12 weeks

Secondary Outcomes (1)

  • pregnancy rate

    12 weeks

Study Arms (3)

Somatropin group

EXPERIMENTAL

Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day

Drug: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.

dehydroepiandrosterone

EXPERIMENTAL

dehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day

Drug: DHEA plus folic acid 400mcg per day

Standard care

ACTIVE COMPARATOR

Patients will receive standard care will receive folic acid 400 mcg per day

Dietary Supplement: control group

Interventions

control groupDIETARY_SUPPLEMENT

Patients will receive folic acid 400 mcg per day

Standard care
Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.DRUG

Patients will receive Somatropin (4IU for 1 month)1 S.C injection every 3 days for at least 1 month plus, folic acid 400 mcg per day.

Somatropin group
DHEA plus folic acid 400mcg per dayDRUG

Patients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day

dehydroepiandrosterone

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least two of the following three criteria had to be present after maximal stimulation:
  • Advanced maternal age (\>40 years) or any other risk factor for Poor Ovarian Response (POR).
  • ≤3 oocytes with a conventional stimulation protocol).
  • An abnormal ovarian reserve test \[i.e. antral follicle count (AFC) less than 5-7 follicles or anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml\].

You may not qualify if:

  • Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction.
  • Any pelvic pathology such as hydrosalpinx, uterine anomaly.
  • Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

Related Publications (1)

  • Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.

    PMID: 11006185BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Human Growth HormoneFolic AcidDehydroepiandrosteroneControl Groups

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesTestosterone CongenersGonadal Steroid HormonesGonadal HormonesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy, Beni-Suef University

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 7, 2026

Study Start

October 10, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 12, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12

Locations

EG(1)