Double Stimulation in Women With Low Prognosis in ART

NCT ID: NCT04531644

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-14

Study Completion Date

2024-03-30

Brief Summary

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The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.

Detailed Description

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The patients will be allocated into two groups: control and study group \_ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.

\_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.

Conditions

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Assisted Reproductive Techniques

Keywords

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double ovarian stimulation low prognosis women ongoing pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study

the patients in this group will be treated with double stimulation

Group Type EXPERIMENTAL

double stimulation

Intervention Type PROCEDURE

the patients will be treated with two consecutive ovarian stimulations in one cycle

Control

the patients in this group will be treated with conventional ovarian stimulation

Group Type ACTIVE_COMPARATOR

conventional ovarian stimulation

Intervention Type PROCEDURE

the patients will be treated with one conventional ovarian stimulation in one cycle

Interventions

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double stimulation

the patients will be treated with two consecutive ovarian stimulations in one cycle

Intervention Type PROCEDURE

conventional ovarian stimulation

the patients will be treated with one conventional ovarian stimulation in one cycle

Intervention Type PROCEDURE

Other Intervention Names

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DuoStim

Eligibility Criteria

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Inclusion Criteria

* Age ≤ 40.
* AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
* OR 3 ≤ AFC ≤7.
* Normal shape of uterus (based on ultrasound).
* Body mass index within 28 - 37 kg/m2

Exclusion Criteria

* Asherman's syndrome.
* Endometriosis.
* Leiomyomas distorting the endometrium
* Sperm extracted from surgical procedures (i.e. PESA, TESE).
* Patients refuse to continue participating in the study.
* Patients injected with wrong dose of gonadotropins during the treatment.
* Serious complications or accidents arise forcing the patients to discontinue the treatments.
* Ovarian surgery
* Previous chemotherapy or pelvic irradiation
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role collaborator

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role collaborator

Tu Du Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Le Thi Minh Chau

Head of department of Infertility

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chau TM Le, PhD

Role: STUDY_DIRECTOR

Tu Du Hospital

Locations

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Department of Infertility of Tu Du hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Chau TM Le, PhD

Role: CONTACT

Phone: +84908429006

Email: [email protected]

Anh Q Nguyen, Master

Role: CONTACT

Phone: +84976137562

Email: [email protected]

Facility Contacts

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Chau TM Le, PhD

Role: primary

Anh Q Nguyen, MMSc

Role: backup

References

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Cardoso MCA, Evangelista A, Sartorio C, Vaz G, Werneck CLV, Guimaraes FM, Sa PG, Erthal MC. Can ovarian double-stimulation in the same menstrual cycle improve IVF outcomes? JBRA Assist Reprod. 2017 Sep 1;21(3):217-221. doi: 10.5935/1518-0557.20170042.

Reference Type RESULT
PMID: 28837031 (View on PubMed)

Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.

Reference Type RESULT
PMID: 25444501 (View on PubMed)

Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

Reference Type RESULT
PMID: 26921622 (View on PubMed)

Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.

Reference Type RESULT
PMID: 27020168 (View on PubMed)

Other Identifiers

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CS/TD/20/05

Identifier Type: -

Identifier Source: org_study_id