NCT04769401

Brief Summary

Thanks to recent advances in clinical practice and laboratory, embryo cryopreservation has become the first-line procedure in assisted reproductive technology. Embryo freezing process; Prevention of ovarian hyperstimulation syndrome is becoming an accepted practice for a growing number of indications, including preimplantation genetic testing (PGT), late follicular phase progesterone elevation, and embryo-endometrial asynchrony. Progesterone; plays a key role in the preparation of the endometrial cavity for embryo attachment. Supplementary progesterone preparations can be used to prevent luteal phase defects and provide progesterone support during cycle preparations for frozen-thawed embryo transfer. Our aim in this study is to show the effect of serum progesterone level on pregnancy outcomes on the day of embryo transfer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 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, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

February 14, 2021

Last Update Submit

January 17, 2022

Conditions

InfertilityIVFProgesterone

Keywords

progesteroneinfertilityestradiol

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rates

    Pregnancy rates of the participants

    average of 1 year

Study Arms (2)

Normal Progesterone group

EXPERIMENTAL

Progesterone level ≥ 10 ng/mL on ET day.

Other: Normal Progesterone group

Low Progesterone group

ACTIVE COMPARATOR

Progesterone level \<10 ng/mL on ET day.

Other: Low Progesterone group

Interventions

Normal Progesterone groupOTHER

Progesteron supplementation was initiated by the use of 100 mg of a vaginal progesterone tablet two times daily (Lutinus, Ferring Pharmaceuticals) plus 250 mg of intramuscular hydroxyprogesterone caproate in oil twice a week (IMHPC) as luteal phase support (referred to as day 0 of progesterone administration).

Normal Progesterone group
Low Progesterone groupOTHER

Progesterone level \<10 ng/mL on ET day. If serum progesterone levels were \<10 ng/ml at ET day, 25 mg/d of SC progesterone daily (Prolutex) was given to patients and ET was performed on the same day and the blood sample was taken 2 days later to check serum progesterone levels.

Low Progesterone group

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) ≤25 kg/m2
  • between 18 and 41 years old and with FSH levels on cycle day 3 of ≤12 mIU/ml

You may not qualify if:

  • patients with uncorrected intracavitary structural uterine anomalies including unicornuate, bicornuate or didelphic uterus
  • recurrent miscarriage
  • presence of hydrosalpinx
  • cycle cancelation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acıbadem Kozyatağı Hospital

Istanbul, Turkey (Türkiye)

Location

Bezmialem Foundation University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Gardner DK, Lane M. Culture and selection of viable blastocysts: a feasible proposition for human IVF? Hum Reprod Update. 1997 Jul-Aug;3(4):367-82. doi: 10.1093/humupd/3.4.367.

    PMID: 9459282BACKGROUND

  • Rienzi L, Gracia C, Maggiulli R, LaBarbera AR, Kaser DJ, Ubaldi FM, Vanderpoel S, Racowsky C. Oocyte, embryo and blastocyst cryopreservation in ART: systematic review and meta-analysis comparing slow-freezing versus vitrification to produce evidence for the development of global guidance. Hum Reprod Update. 2017 Mar 1;23(2):139-155. doi: 10.1093/humupd/dmw038.

    PMID: 27827818RESULT

  • Loutradi KE, Kolibianakis EM, Venetis CA, Papanikolaou EG, Pados G, Bontis I, Tarlatzis BC. Cryopreservation of human embryos by vitrification or slow freezing: a systematic review and meta-analysis. Fertil Steril. 2008 Jul;90(1):186-93. doi: 10.1016/j.fertnstert.2007.06.010. Epub 2007 Nov 5.

    PMID: 17980870RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • pınar özcan

    Bezmialem Foundation University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2021

First Posted

February 24, 2021

Study Start

February 1, 2021

Primary Completion

November 21, 2021

Study Completion

November 21, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)