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InfertilityNCT02827656

Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS

A study testing Decapeptyl and hCG luteal support in people with Infertility, run by Meir Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare two luteal support protocols in In vitro fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome (OHSS). Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Decapeptyl and hCG luteal support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Aug 2016to Dec 2017
Phase
Interventional
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • IVF treatment
  • GnRH antagonist protocol
  • GnRH agonist triggering of ovulation
  • High risk for OHSS as expressed by either E2 serum level >2500 pg/ml

Who cannot join

  • background maternal morbidity
  • Any protocol other than GnRH antagonist protocol
  • hCG triggering of ovulation
  • E2 serum level >4500 pg/ml
  • Aspiration of >25 ova
  • Embryo transfer prior to day 5

Trial locations and contacts

No sites are listed yet.

Anat Klement, MD contact

anat.klement@gmail.com

Helsinki Committee MMC contact

97297471588

About this study

Official title: Luteal Phase Support With Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRh) Agonist in IVF Patients Who Are Risk for Developing OHSS

The purpose of this study is to compare two luteal support protocols in In vitro fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation triggering is as good as low dose hCG on day 3 post triggering..

Read the detailed description

This is randomized clinical trial studying two luteal support protocols of In vitro fertilization patients (IVF) treated by a GnRH antagonist (GnRH ant) protocol and are at risk of developing ovarian hyperstimulation syndrome (OHSS). The randomization procedure will be performed by a third party in the hospital by using a randomization table: patients fulfilling the inclusion and exclusion criteria and giving their informed consent will be randomized into one of two arms. This study does not include any intervention affecting the ovarian stimulation and is solely intended to test the post ova pickup period.

One arm will be treated by luteal Decapeptyl on days 3, 6,9 post ovulation triggering. Second arm will be treated by low dose hCG on day 3 post triggering. All patients to be recruited are treated for acceptable IVF indications in Meir medical center (MMC) and their registry is computerized in the general system of MMC. For the purpose of the study we will use the only the data of patients recruited to the study and were giving their informed consent. Each patient recruited will have a unique study identity (ID) . The patients' information will be pooled from the computerized file into an Excel spread sheet: in this Excel file the names will be erased and only the unique study ID will appear. The information regarding the coding key will be kept as a hard copy in a locked room inside the IVF unit in a special study folder. The study was approved by MMC institutional Helsinki board.

The data retrieved for each patients is not unique for the study but includes the basic variables monitored in every IVF cycle : Estradiol serum levels (E2), Progesterone serum levels (P), number of follicles as counted by trans-vaginal ultrasound, endometrial thickness as measured by trans-vaginal ultrasound, Follicle stimulating hormone (FSH) dosing, number of stimulation days, number of eggs retrieved, fertilization rate, blastulation rate, number of embryos transferred, embryo quality, positive pregnancy test, implantation rate, presence of a clinical pregnancy, presence of OHSS. Since these are mandatory variables in the treatment we do not expect any missing data. In addition to these mandatory data the study patients will be performing two additional blood tests on day 3 post ovum pickup and on the transfer day itself (day 5 post ovum pickup) including Estradiol serum levels (E2) and Progesterone serum levels (P).

Outcome measures: Day of transfer Progesterone serum levels, OHSS rate, implantation rate, clinical pregnancy rate.

Sample size calculation based on Kol S et al 2015, regarding the day of transfer Progesterone level (pooled standard deviation: 40nmol/L), alpha of 5%, 80% power, then a non-inferiority study will require 22 patients in each group and a total of 44 patients. Once including an expected 10% chance of freeze all in this population we will include 50 patients.

Statistical analysis: Analysis of data was performed using the SPSS 23.0 computer package (SPSS Inc., Chicago, IL). Normally distributed data were analyzed by student t test . χ2 or Fisher's exact test will be used for comparisons of rates and proportions. All P values were tested as two-sided and considered significant at less than 0.05.

Conditions
Infertility
Being tested
Decapeptyl, hCG luteal support
Keywords
Fertilization in vitro, Luteal Phase, ovarian hyperstimulation syndrome
Medical subject headings
Infertility, Ovarian Hyperstimulation Syndrome

What participants receive

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

  • DecapeptylDrug

    luteal support as described and vaginal progesterone 200 mg 3 times a day

  • hCG luteal supportDrug

    luteal support as described and vaginal progesterone 200 mg 3 times a day

Study groups in NCT02827656
Study groupRoleWhat they receive
Decapeptyl supportExperimentalS.C single luteal Decapeptyl 0.1 mg on days 3, 6,9 post ovulation triggering
Receives: Drug: Decapeptyl
hCG luteal supportActive comparatorS.C single luteal S.C recombinant hCG 50 micrograms on days 3 ovulation triggering
Receives: Drug: hCG luteal support

What is being measured

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

  1. Progesterone serum level

    Measured: day 5 post ovum pickup

Secondary outcomes (3)

  1. positive pregnancy test

    Measured: 9-12 days post embryo transfer

  2. implantation rate

    Measured: 30-33 days post embryo transfer

  3. clinical pregnancy rate

    clinical pregnancy is considered as a presence of a viable embryo (heart activity present)

    Measured: 30-33 days post embryo transfer

Timeline

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

  1. First posted11 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02827656
Sponsor's protocol ID
056-16MMC
Status last verified
Jun 2016
First submitted
6 Jul 2016
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.

    PubMed 21828116

  • Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD008046. doi: 10.1002/14651858.CD008046.pub4.

    PubMed 25358904

  • Whelan JG 3rd, Vlahos NF. The ovarian hyperstimulation syndrome. Fertil Steril. 2000 May;73(5):883-96. doi: 10.1016/s0015-0282(00)00491-x.

    PubMed 10785212

  • Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grondahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005 May;20(5):1213-20. doi: 10.1093/humrep/deh765. Epub 2005 Mar 10.

    PubMed 15760966

  • Griesinger G, Schultz L, Bauer T, Broessner A, Frambach T, Kissler S. Ovarian hyperstimulation syndrome prevention by gonadotropin-releasing hormone agonist triggering of final oocyte maturation in a gonadotropin-releasing hormone antagonist protocol in combination with a "freeze-all" strategy: a prospective multicentric study. Fertil Steril. 2011 May;95(6):2029-33, 2033.e1. doi: 10.1016/j.fertnstert.2011.01.163. Epub 2011 Mar 2.

    PubMed 21371705

  • Kol S, Breyzman T, Segal L, Humaidan P. 'Luteal coasting' after GnRH agonist trigger - individualized, HCG-based, progesterone-free luteal support in 'high responders': a case series. Reprod Biomed Online. 2015 Dec;31(6):747-51. doi: 10.1016/j.rbmo.2015.09.001. Epub 2015 Sep 9.

    PubMed 26507279

Questions about this trial

What is this clinical trial studying?

A study testing Decapeptyl and hCG luteal support in people with Infertility, run by Meir Medical Center.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Anat Klement, MD (anat.klement@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progesterone serum level (time frame: day 5 post ovum pickup). 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 NCT02827656, which also lists 6 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 12 Jul 2016.

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