NCT04547699

Brief Summary

A randomized clinical trial to evaluate the effect of cytokine supplementation in embryo culture medium with various protein concentrations aiming to evaluate the effects of cytokines (CYK) integration into the human in vitro culture medium with high and low human serum albumin (HSA) concentrations on live birth rates after intracytoplasmic sperm injection (ICSI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

August 30, 2020

Last Update Submit

June 16, 2023

Conditions

ICSI

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    the number of deliveries that resulted in at least one live born baby (\>20 weeks gestational age or 500 gm birth weight ) expressed per 100 embryo transfer,

    9 months

Secondary Outcomes (10)

  • Fertilization rate

    4 weeks

  • Top quality day 3 embryos

    4 weeks

  • Blastocyst formation rate

    4 weeks

  • Top blastocyst rate

    4 weeks

  • Available embryo rate

    4 weeks

  • +5 more secondary outcomes

Study Arms (3)

HSA

PLACEBO COMPARATOR

A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein,

Combination Product: A single step culture medium

CYK+ high HSA

EXPERIMENTAL

A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein, supplemented with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma),and 5ng/mL LIF (SRP9001 Sigma).

Combination Product: A single step culture medium

CYK+low HSA

ACTIVE COMPARATOR

A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global protein, supplemented with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF (SRP9001 Sigma).

Combination Product: A single step culture medium

Interventions

A single step culture mediumCOMBINATION_PRODUCT

A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK

CYK+ high HSACYK+low HSAHSA

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who fitted the medical definition of infertility "One year of unprotected intercourse but not pregnant".

You may not qualify if:

  • History of ovarian or adnexal surgery.
  • Suspicious findings of ovarian malignancy.
  • Presence of endocrine disorders such as diabetes mellitus, hyper-prolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing's syndrome, and adrenal insufficiency.
  • Presence of Globozoospermia (100% round-headed spermatozoa)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura Integrated fertility Center

Al Mansurah, Dekahlia, Egypt

Location

Mansoura Integrated Fertility Center

Al Mansurah, 3311, Egypt

Location

Related Publications (3)

  • Fukui Y, Hirota Y, Matsuo M, Gebril M, Akaeda S, Hiraoka T, Osuga Y. Uterine receptivity, embryo attachment, and embryo invasion: Multistep processes in embryo implantation. Reprod Med Biol. 2019 May 24;18(3):234-240. doi: 10.1002/rmb2.12280. eCollection 2019 Jul.

    PMID: 31312101BACKGROUND

  • Guzeloglu-Kayisli O, Kayisli UA, Taylor HS. The role of growth factors and cytokines during implantation: endocrine and paracrine interactions. Semin Reprod Med. 2009 Jan;27(1):62-79. doi: 10.1055/s-0028-1108011. Epub 2009 Feb 5.

    PMID: 19197806BACKGROUND

  • Fawzy M, Emad M, Elsuity MA, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Sabry M, Nour M, Rasheed SM. Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial. Fertil Steril. 2019 Nov;112(5):849-857.e1. doi: 10.1016/j.fertnstert.2019.07.012. Epub 2019 Sep 21.

    PMID: 31551154BACKGROUND

Study Officials

  • Emad M Sedeek, MS

    MIFC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, randomized, double-blinded and prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior embryologist in IVF laboratory,

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 14, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

all IPD will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months after completion and for 3 months

Locations

EG(2)