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Infertility, FemaleNCT05076981

Progesterone Levels During Ovulation and Luteal Phase

An observational study of Infertility, Female, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (IUI), time intercourse (TI) or frozen-thawed embryo transfers (FET). Two possible protocols can be used for natural cycles, with or without hCG trigger. Read more about this study

Who is it for?
Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female
What is being tested?
human chorionic gonadotropin
Type of treatment
Injection or infusion
How many people
6 participants
Where
1 siteUnited Arab Emirates
Study dates
23 Sep 2021to 30 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: healthy women with spontaneous ovulation

Who may be able to join

  • Healthy women below 40 years
  • Regular and Ovulatory cycles

Who cannot join

  • Previous adnexal surgery
  • Endometriosis
  • PCOs
  • Using hormonal contraception during the previous 2 months: OCP, progesterone IUD

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • ART Fertility Clinics LLC

    Abu Dhabi, 60202

Other trials in United Arab Emirates

About this study

Official title: Progesterone Levels During Ovulation and Luteal Phase in Spontaneous Natural Ovulatory Cycles vs Modified Natural Cycle. A Prospective Study

Natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (IUI), time intercourse (TI) or frozen-thawed embryo transfers (FET). Two possible protocols can be used for natural cycles, with or without hCG trigger. Usually, studies including natural cycles consider both options as equivalent, not considering the possible bias that the exogenous hCG (human chorionic gonadotrophin) might have. In this prospective study, Investigators aim to evaluate the differences in the hormonal profile during the ovulation when it occurs spontaneously vs triggered with a bolus of hCG.

Read the detailed description

For the pure natural cycle (PNC), ovulation will be detected by a combination of ultrasound monitoring the follicular growth and serial measurement of luteinizing hormone (LH), estradiol (E2) and progesterone (P4) levels, which is recognised to be the most accurate method of correctly identifying ovulation.

For the modified natural cycle (MNC), a bolus of rhCG 6500 IU subcutaneous (sc) will be administered when 1 dominant follicle reaches 17mm or above, after excluding previous LH surge. This is the first prospective study where the differences on the hormonal profile for ovulation will be studied.

HYPOTHESIS:

H0: The hormonal profile is not different between the PNC and the MNC H1: The hormonal profile is different between the PNC and MNC

Administration of hCG is a popular method for triggering ovulation since it may avoid the need to perform IUI or FET at weekends. However, it is an intervention compared with the detection of the spontaneous LH rise. Moreover, due to the presence of hCG receptors in the human endometrium, administration of hCG might interfere with endometrial receptivity. Previous publications evaluating pregnancy rates demonstrated that the use of hCG injection during the natural cycle reduces the pregnancy rates, in FET and IUI. It remains unclear what might be the mechanism to explain the lower pregnancy rates: a possible direct effect of hCG on the hCG receptors of the endometrium or a modification of the hormonal profile after the administration of the hCG, affecting the window of implantation (WOI).

Being tested
human chorionic gonadotropin
Keywords
luteal phase, natural cycle, human chorionic gonadotropin, progesterone, progesterone rise, ovulation
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human chorionic gonadotropinDrug

    Also called Ovitrelle

    once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously

Study groups in NCT05076981
Study groupRoleWhat they receive
Pure Natural Cycle* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1) * TVUS day 9-10 of cycle to identify dominant follicle. * Blood test for IVF1 every 24h until identification of the LH surge. * The LH surge will be diagnosed when the concentration rises by 180% above the latest serum value available in that patient and continued to rise thereafter (Fatemi et al, 2010). * Once the LH rise is detected, blood test for IVF1 to be performed after 2h, and then every 12h after LH rise for 2 days. * During luteal phase, IVF1 day 7 after LH rise and day 14 after LH rise.
Modified Natural Cycle* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1) * TVUS day 9-10 of cycle to identify dominant follicle. * Once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously. IVF1 to be performed just before the rhCG-administration. * IVF1 2h after rhCG. * IVF1 every 12h for 2 days after rhCG. * During luteal phase, IVF1 day 7 after rhCG and day 14 after rhCG.
Receives: Drug: human chorionic gonadotropin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in hormone levels

    Small sample data will be analyzed with the use of non-parametric test like Wilcoxon test to a paired a test of difference in hormones levels of the patients represented in both cycles (PNC and MNC) (dependent samples). This test will be preferred due to non-independent interval or ratio data in addition not to meet the normality or homogeneity of variances assumptions as paired t-test.

    Hormonal pattern over the days (measured for some days during cycle 1 and cycle 2) will be analyzed using trend analysis (line fit).

    Measured: 35 days

Secondary outcomes (2)

  1. Number of visits in luteal phase

    Number of visits will be analyzed. The differences will be analyzed across PNC and MNC with CI. Fisher's exact test.

    Measured: 17 days

  2. Luteal phase length

    Luteal phase length will be analyzed. The differences will be analyzed across PNC and MNC with CI. Fisher's exact test.

    Measured: 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start23 Sep 2021
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076981
Sponsor's protocol ID
2107-ABU-009-LM
Status last verified
Mar 2023
First submitted
20 Sep 2021
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Licht P, Fluhr H, Neuwinger J, Wallwiener D, Wildt L. Is human chorionic gonadotropin directly involved in the regulation of human implantation? Mol Cell Endocrinol. 2007 Apr 15;269(1-2):85-92. doi: 10.1016/j.mce.2006.09.016. Epub 2007 Feb 14.

    PubMed 17367920

  • Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

    PubMed 20097333

  • Kyrou D, Kolibianakis EM, Fatemi HM, Grimbizis GF, Theodoridis TD, Camus M, Tournaye H, Tarlatzis BC, Devroey P. Spontaneous triggering of ovulation versus HCG administration in patients undergoing IUI: a prospective randomized study. Reprod Biomed Online. 2012 Sep;25(3):278-83. doi: 10.1016/j.rbmo.2012.05.005. Epub 2012 May 23.

    PubMed 22796236

  • Connelly LM. Pilot studies. Medsurg Nurs. 2008 Dec;17(6):411-2. No abstract available.

    PubMed 19248407

  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PubMed 18183564

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Female, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in hormone levels (time frame: 35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076981, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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